Clinical Research Associate Jobs in San Diego, CA

Description Job Title: Principal Clinical Research Associate Position type: FLSA: Full time Exempt Department: Finance ID: Clinical Operations 2101-J36190-BF Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit ************************** and engage with us on LinkedIn and Twitter. The Opportunity The Principal Clinical Research Associate (PCRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure successful execution of clinical monitoring. PCRAs have expertise in on-site and remote clinical trial monitoring and oversight, ensuring subject safety, protocol compliance and data integrity, and implementation of clinical trial documents and plans. As an Avidity representative in the field, the PCRA will support establishing, building, and maintaining collective relationships with KOLs, investigators and site staff. The PCRA is relied upon to instill, promote, and maintain a culture of organizational excellence and monitoring team collaboration. Strong initiative, organizational skills, and leadership by example required. What You Will Contribute May review data quality reports for trends and escalation of monitoring issues. Assist clinical trial team with oversight of CRO monitoring activities, assumptions, and metrics, including site qualification, site initiation, interim monitoring, and close out visits. Assist CTM with setting expectations for monitoring report content as outlined in the annotated report, and finalization of associated reports and follow-up letters; escalate deficiencies or quality issues to CTM. Conduct Oversight Visits to assess the Clinical Research Associate (CRA) and/or site performance to evaluate data integrity, compliance with the protocol, Good Clinical Practice (GCP), and any applicable local/regional regulations. Assist with the review of CRO clinical monitoring Standard Operating Procedures (SOPs), processes, and best practices to ensure Avidity monitoring expectations are met. Participate in User Acceptance Testing (UAT) for EDC, IRT, and study vendor portals; review at initial launch and with amendments, as needed. Review clinical trial documents such as clinical monitoring plans, study operations manual, monitoring visit report and letter templates, case report forms (CRF) and CRF completion guidelines, site tools and worksheets, and other study documents requiring clinical review as needed. Participate in the identification and review of trial-specific EDC data tracking and metrics. Work with Data Manager and CTM to review data listings for accuracy, support data discrepancy management, and provide training/retraining to site staff and CRAs as needed. Collaborate, develop, and deliver study-specific training for CRO clinical study team, field CRAs, investigative site staff, and vendors. Assist with planning and attend investigator meetings (IM); may present during CRA training. Attend, present, and train investigative site staff during site qualification visits and site initiation visits, as required. Assist with investigative site regulatory inspection preparation, support, and follow-up. May participate in vendor capabilities presentations and bid defense meetings for vendor identification and selection. May participate in and support corporate patient advocacy efforts. Represent Avidity monitoring oversight initiatives and, if appropriate, facilitate cross-functional study collaboration. Contribute to ongoing process improvement and department initiatives. Participate in corporate collaboration meetings and attend industry meetings and conferences. Travel as needed per study status and timelines, in addition to other essential study meetings (i.e., Investigator meetings, study kick-off meetings, bid defenses, vendor meetings, etc.). What We Seek Bachelor's Degree or equivalent combination of education and experience in science or health-related field. Advanced Degree preferred. 8+ years of industry experience conducting clinical site monitoring, management, and oversight; elements of clinical trial management also preferred. Knowledge of regulatory and compliance requirements for clinical research, including but not limited to, US CFR, ICH, GCP, GDP, EU/UK GDPR. Team leadership experience within a cross-functional matrix environment. Demonstrated excellent presentation, communication (oral and written), teamwork, organizational, interpersonal, and critical thinking skills. What We will Provide to You: The base salary range for this role is $169,100 - $186,900. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors. Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program. Avidity Biosciences 10578 Science Center Dr. Suite 125

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Thorough understanding of study protocol and manuals. Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. Participate in monitoring activities to achieve study milestones. Utilize internal and study specific software and tools. Assist in training new monitors on study specific or onsite procedures as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Experience in AD research is preferred. Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.91 - $51.94. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************

We are seeking a highly motivated and qualified individual to join our Clinical Department as an in-house CRA and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The in-house CRA (CRA) is responsible under supervision for supporting the administration and progress of clinical trial(s) on behalf of ADARx Pharmaceuticals. The CRA monitors the research procedures and ensures that research is always following the proper clinical trial protocol to obtain the correct data. The CRA also ensures that these processes are performed in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP). Essential Responsibilities: Assist with the identification and set up of the trial sites; ensuring each site has the trial materials, including the investigational product. Responsible for study start- up activities and tracking study metrics (e.g. feasibility data, ICF review, regulatory document collection and review, and Trial Master File tracking). Assure regulatory compliance of investigational sites with ADARx Pharmaceuticals SOPs, FDA regulations, and ICH guidelines. Review and approve monitoring visit reports. Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring. Collect completed CRFs and other trial materials throughout and at the end of the study. Maintain internal document management system and TMF ensuring important documents and communication filed timely and appropriately. Assist and support data query process. Verify internal data listings. Generate reports or notes to files, and file/collate trial documentation and reports. Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects. Utilize clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation. Assist with preparing study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents. Assist with coordination and be responsible for the design of study materials such as Case Report Forms (CRFs), patient diaries, study participation materials, and source documents. Assist with protocol development and study report completion. Assist with planning and participating in investigator meetings. Assist with preparing training materials used to train site staff during the SIV and at other times to trial-specific industry standards. May include monitoring the trial throughout its duration for specific tasks or activities. Coordinate study supplies at all sites. Assist with preparing final reports. Archive study documentation and correspondence as appropriate. Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience. Establish and maintain excellent working relationships with critical collaborative partners throughout the company. Maintain all corporate standards for lab safety and hazardous material management. Other duties as assigned. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications : BA/BS in a health-related field or ADN. Minimum 4 years of relevant clinical research experience. Clinical research related monitoring or study coordinator experience. Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations. Proficiency working with Microsoft Office Suite Products. Ability to travel (domestic/international) if necessary. Preferred Qualifications: Global clinical trial experience preferred. Clinical research or life sciences degree preferred. Required Key Attributes: Must be able to work independently with supervision as needed. Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role. Strong problem-solving skills and a proactive attitude towards exploring new approaches. Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism. Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment. Compensation: This is a full-time position, Monday-Friday, occasional overtime. Pay is commensurate with experience. Equity-based compensation Performance-based bonuses 401(k) with Company Match Medical, Dental, Vision Flexible Spending Account Life Insurance Employee Assistance Program Employee Discounts Gym Membership Paid Vacation Paid Holidays Paid Sick, Jury Duty, Bereavement Work Authorization: United States (Required) Background Check As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law. Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses. Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. * Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team * Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials * Ensures consistency across studies and provide oversight of all clinical studies within assigned area * May serve as a Clinical Trial Lead or Co-Lead as needed * May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities * Serves as a key cross functional collaborator; initial point of escalation cross functions Key Responsibilities * Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical development and lifecycle planning * Lead implementation of assigned clinical development and/or lifecycle plans * Maintain an advanced understanding of all protocols within assigned Program * Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members * Represent Clinical Science Team on the Program Team as appropriate/requested * Support resourcing and budget planning activities for team * Review and present data and information to external investigators and internal stakeholders as needed * Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice * Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management * Author/Review abstracts/publications * Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as: * Evaluation of innovative trial designs * Protocol and ICF development * Site-facing activities * CRA training materials * Data quality activities; ensure consistent, quality data review across trial teams * Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities * Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Qualifications & Experience * Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) Experience Requirements: * 5+ years of experience in clinical science, clinical research, or equivalent * Experience in driving, managing and collaborating in a team/matrix work environment * Recognized internally and externally as a Therapeutic Area and Functional expert * Preferred experience in Neuroscience and/or Psychiatric Key Competency Requirements: * Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations * Ability to plan and manage * Advanced ability to analyze, interpret, and present data * Advanced knowledge and skills to support program specific data review, trend identification, data interpretation * Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements * Advanced medical writing and presentation skills * Ability to self-supervise, and act independently to identify/resolve program level issues * Proficient critical thinking, problem solving, decision making skills * Effective planning and time management * Advanced verbal, written and interpersonal skills (communication skills) * Adaptable and analytical * Strong presentation skills / leadership presence * Commitment to Quality * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism * Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) * Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools * Travel Required * Domestic and International travel may be required. Travel Required * Domestic and International travel may be required. The starting compensation for this job is a range from $182,000-$257,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #li-hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Join our team as a Clinical Research Site Manager, where you'll play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements. Essential Functions Site Monitoring: Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs. Training & Communication: Provide protocol training and maintain regular communication with sites to manage expectations and address issues. Quality Assurance: Evaluate site practices for protocol adherence and escalate quality issues as needed. Study Progress: Track regulatory submissions, recruitment, enrollment, case report form (CRF) completion, and data query resolution. Support the start-up phase as required. Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations. Mentorship: Mentor clinical staff through co-monitoring and training visits. Collaboration: Work closely with study team members to support project execution. Travel: 6-10 DoS per month typical expectation, can be exceptions given the nature of the position. Qualifications Education: BS Degree in a scientific discipline or healthcare preferred. Experience: At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology. Knowledge: In-depth understanding of GCP and ICH guidelines. Skills: Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads. Communication: Strong written and verbal communication skills with a good command of the English language. Organization: Excellent organizational and problem-solving skills. Management: Effective time and financial management abilities. Interpersonal: Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $87,200.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

The Global Clinical Scientist, Clinical Development will have a key role in supporting the clinical development of seralutinib for the treatment of pulmonary arterial hypertension (PAH). This includes contributing and having day-to-day responsibilities related to the conduct of the Phase 3 PROSERA study in PAH. This role will work in conjunction with the Clinical Development Lead, Study Teams, CRO, Clinical Operations, and Medical Affairs teams to resolve site challenges, support recruitment efforts, answer protocol related questions during trial execution, and to assist in the ensuring that the clinical data as part of the phase 3 program is of the highest quality. Essential Duties and Responsibilities Provide day-to-day oversight on the global Phase 3 study in PAH partnered with the Clinical Operations Co-lead. Under Direction of the Program Clinical Development Lead, provide general clinical and scientific support in all aspects of the PAH Clinical Development program, including the design, preparation, general conduct, analyses, and reporting of the clinical studies. Review and input on clinical and regulatory documents e.g. clinical study reports Participate in authorship of clinical/regulatory documents including clinical development plans, investigator brochures, safety risk management plans, PIPs and regulatory briefing packages. Review data listings to ensure the data is of the highest quality. Cultivate strong relationships and robust communication among the clinical study/project team and the development organization. Participate in weekly meetings with clinical operations, CRO, others, as a Clinical Development representative Liaise with other Gossamer Bio functional areas as needed to support the clinical study and PAH program. Provide support for the GB002 clinical development plan for PAH incorporating pre-clinical, clinical, regulatory, operational, biometric, CMC, and commercial strategies in accordance with corporate objectives. Provide feedback on specific sites and regions, and therapeutic area guideline trends to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification. Leverage relationships to ensure interest and commitment from clinical investigators for study enrollment and open communication regarding feedback to Gossamer. Identifies potential issues and leads contingency planning efforts; leads team problem solving efforts and applies decision-making tools and techniques, driving teams to make effective and efficient decisions. Contributes to the analysis and summary of the clinical findings from studies to support decisions regarding safety and efficacy i.e. study documents, clinical study reports, regulatory documents, or publications for some documents and sections, may function as the primary author as the subject matter expert. Conduct site visits with investigators and study staff (when appropriate) to foster relationships, ensure study conduct is of high quality and consistent with expectations established at study initiation. Support clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). JOB QUALIFICATIONS Advanced Degree in Life Sciences (PhD, Pharm D, or MS) 3-5+ years of experience in clinical science, clinical research, or equivalent. Therapeutic expertise in pulmonary arterial hypertension (PAH), pulmonary hypertension in interstitial lung disease (PH-ILD), idiopathic pulmonary fibrosis (IPF), or rare diseases. Broad knowledge of the drug development process including early and late phase development Experience in data analysis and utilizing Excel and power point Experience in leading Phase 2 and Phase3 studies and study teams Experience in writing and editing scientific and regulatory documents including clinical protocols and regulatory documents. Advanced analytical and influencing skills and proficient at data interpretation. Experience in conducting literature searches and synthesizing the information. Expert understanding of global clinical study design and drug development processes Strong understanding of GCP and ICH Guidelines Excellent interpersonal skills; able to work independently and collaboratively; exercise sound judgment, escalate issues when necessary, and motivate team members. Experience in presenting at both internal and external meetings. Office Environment based in San Diego, CA or Remote. Up to 30 % travel required as needed to support clinical study/program. Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment. The expected salary range for this position is $183,000 to $230,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below: Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit ******************************************************* Vaccination Policy: Gossamer Bio is committed to complying with federal, state and local law on vaccinations. Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law. California Consumer Privacy Act (CCPA) Notice for California Residents: This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller. Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller's Privacy team can be contacted at privacy@gossamerbio.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Clinical Research Associate Job Location: Carlsbad Responsibilities: Clinical trial design in partnership with Director of Clinical Research and the Clinical team. Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines. Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines. Assists with the development and approval of clinical trial documents. Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity. Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory. Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol. Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies. Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials. Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals. Build positive relationships with clinical trial investigators and their research team. Coordinate and oversee other key research studies/activities as requested by the Director of Research. Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team. Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims. Requirements: Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred. 3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology. Experience working with industry sponsored clinical trials. Experience working in cosmetic and medical dermatology preferred. Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team. Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously. Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously. Ability to problem solve and troubleshoot challenges in a timely manner. General knowledge of current dermatological device systems, instruments, and products preferred. Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools. Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team. Ability to communicate effectively both verbally, and in writing. Ability to create professional reports, presentations, and reporting. Dedication and embodiment of our core values. Must possess a valid driver's license. 15% travel may be required. Physical Requirements: Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel. This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad. Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits. Ability to lift up to 15 lbs.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Clinical Research Associate Job Location: Carlsbad Responsibilities: * Clinical trial design in partnership with Director of Clinical Research and the Clinical team. * Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines. * Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines. * Assists with the development and approval of clinical trial documents. * Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity. * Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory. * Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol. * Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies. * Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials. * Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals. * Build positive relationships with clinical trial investigators and their research team. * Coordinate and oversee other key research studies/activities as requested by the Director of Research. * Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team. * Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims. Requirements: * Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred. * 3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology. * Experience working with industry sponsored clinical trials. * Experience working in cosmetic and medical dermatology preferred. * Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team. * Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously. * Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously. * Ability to problem solve and troubleshoot challenges in a timely manner. * General knowledge of current dermatological device systems, instruments, and products preferred. * Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools. * Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team. * Ability to communicate effectively both verbally, and in writing. * Ability to create professional reports, presentations, and reporting. * Dedication and embodiment of our core values. * Must possess a valid driver's license. * 15% travel may be required. Physical Requirements: * Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel. * This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad. * Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits. * Ability to lift up to 15 lbs.

Associate Clinical Scientist for Polaris Pharmaceuticals, Inc. Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company's lead therapeutic, ADI-PEG 20, is a novel biologic in late stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including mesothelioma, sarcoma, melanoma, acute myeloid leukemia and others. We are seeking an experienced, independent clinical scientist professional with strong analytical skills and business acumen. The successful candidate will be a member of the Clinical Affairs group, working closely with the clinical and research groups. The candidate will have basic familiarity with current oncology treatment modalities and approaches to clinical and pre-clinical drug development. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable and willing to take on additional responsibilities as required. Responsibilities: Contributes to clinical and pre-clinical program development strategy and execution Analyzes and interprets study data, and prepares scientific reports and presentations Contributes to and authors strategic documents including pre-clinical and clinical sections of regulatory documents such as Investigator's Brochures, IND submission documents, study protocols, statistical analysis plans, responses to Health Authority questions Contributes to study-related advisory boards and investigators' meetings Manages collaborations with external groups including study vendors Leads translational special interest projects Contributes to the development of abstracts, presentations, and manuscripts Assists with clinical site evaluation

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: * Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. * Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. * Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. * Act as main point of contact for assigned clinical sites. * Thorough understanding of study protocol and manuals. * Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. * Participate in monitoring activities to achieve study milestones. * Utilize internal and study specific software and tools. * Assist in training new monitors on study specific or onsite procedures as needed. * Participate in sponsor, internal, and regulatory audits as needed. * Participate in eTMF filing efforts as needed. * Experience in AD research is preferred. * Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.91 - $51.94. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. * Notice of Non-discrimination * Employment Equity * Read USC's Clery Act Annual Security Report * USC is a smoke-free environment * Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************

The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o Mission: Improving Lives by Providing Advanced Therapeutic Options o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research. o Values: o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Role: Senior Clinical Research Coordinator Company: Profound Research Locations: Oceanside, CA Role & Responsibilities: -Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements. -Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met. -Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements & Skills: -BS/BA in Life Sciences or related discipline and 4 years as a Clinical Research Coordinator OR -Associate degree and 6+ years as a Clinical Research Coordinator OR -High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred. -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens. -Excellent attention to detail, organization, and communication with varied stakeholders. Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by coordinating and managing clinical research studies. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. Compensation: $68,000-$71,000 annually Responsibilities Primary Responsibilities · Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines. · Help lead recruitment efforts, developing and refining strategies to meet enrollment targets. · Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria. · Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study. · Study Protocol Design and Oversight: Interprets study protocols, assesses feasibility, and modifies procedures to align with the objectives of clinical trials. · Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures. · Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS). · Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings. · Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines. · Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager. Regulatory Management · Assists with Institutional Review Board (IRB) submissions and protocol amendments. · Collaborate with principal investigators and sponsors and provide insights based on field experience. · Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities. · Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring · Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle. · Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise. · Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes. · Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities · Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements. · Ensures all study-related documents are appropriately filed and accessible for audits. · Manages study registrations and updates in the Clinical Trial Management System and eIRB system. Other Responsibilities · May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel. · Remote and On-Site Study Leadership: · Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel. · Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site. · Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety. Requirements Required Qualifications: · A BA/BS in biological sciences, public health, or equivalent OR 5 plus years of clinical research experience. · Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. · Willingness to obtain a phlebotomy certificate in accordance with the other duties. · Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. · Strong organizational, communication, and problem-solving skills. · Ability to work both independently and collaboratively in a research setting. · US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. · Ability to wear a N95 mask (or similar) if/when required. Preferred: · Certification in clinical research (such as CCRC or CCRP). · Experience with infectious disease studies or military health research. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required. Benefits MPF Federal is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We are recruiting to fill a position to lead business development activities for a small government contracting firm focused on IT Services and Cyber Security for clients in Civil and DoD markets. We can't sponsor H1B. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. Arcetyp LLC is looking for an experienced Clinical Research Coordinator. This role will be responsible for performing the following tasks: DUTIES AND RESPONSIBILITIES: Coordinates and participates in clinical research studies by performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Coordinates and implements procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Assists in the determination of guidelines for the collection of clinical data or administration of clinical studies. EDUCATION AND YEARS OF EXPERIENCE: Bachelor's Degree from an accredited college or university and a minimum experience of 2 years as a Clinical Research Coordinator within the past five years OR current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), OR Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) OR the Society of Clinical Research Associates (SoCRA). Minimum of 2 to 4 years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience. QUALIFICATIONS: Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge. Ability to communicate effectively, both orally and in writing. Possess effective organizational and analytical skills with ability to work independently and in a team environment. Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program. Candidate must possess active/current secret security clearance. Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date Min. Citizenship Status Required: U.S Citizenship. Physical Requirement(s): None Location: Okinawa, Japan COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.

Scripps Health Administrative Services supports our five hospital campuses, 31 outpatient centers, clinics, emergency rooms, urgent care sites, along with our 17,000 employees, more than 3,000 affiliated physicians and 2,000 volunteers. This is a full-time position, with 8- hour varied shifts, some remote work and some on-site work. Home office is located in La Jolla. Join the Scripps Health team and work alongside passionate caregivers and provide patient-centered healthcare. Receive endless appreciation while you build a rewarding career with one of the most respected healthcare organizations nationwide. Why join Scripps Health? AWARD-WINNING WORKPLACE: * Selected as one of the 100 Best Places to Work for 2024 by Fortune Magazine and the Great Place to Work Institute for the 16th time. A remarkable achievement as only five healthcare organizations nationwide made the list, and Scripps is the sole healthcare provider in California to be recognized. * Nearly a quarter of our employees have been with Scripps Health for over 10 years. * Ranked 78th in 2023 PEOPLE Companies that Care. * Ranked 95th in Fortune 100 Best Companies to Work for 2023 Why join this team? Housed within Scripps Health, Scripps Whittier Diabetes Institute (SWDI) is Southern California's leading diabetes center of excellence, committed to providing the best evidence-based diabetes screening, education and patient care across Scripps Hospitals and clinics, and in the surrounding community. Founded in 1981, SWDI's mission is to improve the quality of life for individuals with pre-diabetes, gestational diabetes, type 1 and type 2 diabetes through diverse programs, including diabetes self-management education, behavioral health, clinical research, diabetes prevention, retinal screenings, and professional training and education. SWDI's interdisciplinary team is comprised of endocrinologists, psychologists, nurse practitioners, registered nurses and dietitians, diabetes educators, and researchers. Our current portfolio of research projects is funded by the National Institutes of Health and non-federal sponsors, and evaluates a variety of pharmacological, device, behavioral, and psychological interventions to improve the quality of life for individuals living with diabetes. The Clinical Research Assistant position is ideal for someone who is a fast learner and interested in research and patient care. This position has opportunities to gain data-focused and/or participant-facing experience, with the exact distribution of responsibilities dependent on department needs and candidate qualifications. The Clinical Research Assistant coordinates multiple aspects of clinical trials ensuring regulatory document management, data submission compliance, and IRB submissions meet all standards. Keeps internal data tracking systems up-to-date. Provides superior service to principal investigators and research sponsors within scope of responsibilities. Required Education/Experience/Specialized Skills: * 1 Year in health care setting, or Allied Health professional degree. * Advanced written, oral and interpersonal communication skills. * Strong prioritization, organizational, and problem solving skills. * Strong motivator/communicator in a compact clinical team working with aggressive timelines. * Strong computer skills with Microsoft Office software. * American Heart Association BLS Preferred Education/Experience/Specialized Skills/Certification: * Bachelors degree preferred. * Proficiency in medical terminology * Data management experience * REDCap experience * Bilingual in Spanish and English * Medical Assistant or phlebotomy experience At Scripps Health, you will experience the pride, support and respect of an organization that has been repeatedly recognized as one of the nation's Top 100 Places to Work. You'll be surrounded by people committed to making a difference in the lives of their patients and their teammates. So if you're open to change, go ahead and unlock your potential. Position Pay Range: $26.94-$36.36/hour

Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees: A range of PPO and HMO medical plans PPO and HMO dental plans Vision coverage, long term disability plan, and life/AD&D coverage 401k plan Paid holidays and paid time off A welcoming work environment We're looking for a bright, talented new team member to be a part of our story. Check out this current opening and if you think you may be a fit for the role, please apply. The Role Artemis is looking for a Clinical Research Coordinator for the San Diego office. Under the supervision of the Site Director, the Clinical Research Coordinator I is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Clinical Research Coordinator I manages study conduct from planning through study closeout. Position Type: Full Time Pay Range : $27 - $30/hr Location: San Diego-no remote work Travel: 0% Work Schedule: Monday & Thursday - 8:30am-5pm / Tuesday, Wednesday, and Friday 7:00am-3:30 pm Responsibilities In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending Investigator Meetings Providing the highest level of care for study patients and delivering excellent customer service to the Pharmaceutical clients Assist with lab draws, processing and shipping Qualifications Bachelor's Degree preferred Minimum two years of experience as a Clinical Research Coordinator required Medical assistant or phlebotomist required Commitment and ability to deliver excellent customer service Excellent communication, punctual and responsible Extremely well organized Excellent verbal and written communication skills Trustworthy, reliable; attentive to details Mature and pleasant demeanor Willingness to learn new tasks and grow with the company

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role: Join our dynamic team as a Clinical Trials Specialist supporting Phase I studies while playing a pivotal role in the successful execution of cutting-edge phase I clinical studies at Neurocrine! As a key player in the planning, conduct, and wrap-up of both domestic and global trials, you will be at the forefront of innovation in healthcare. From managing essential documents to ensuring adherence to Good Clinical Practice and maintaining impeccable documentation, you'll be making a meaningful impact on the future of medicine. Collaborate with top-tier professionals both internally and externally and be a driving force in promoting subject safety and data accuracy. Elevate your career and be part of groundbreaking research that changes lives - apply now! _ Your Contributions (include, but are not limited to): Work alongside Clinical Trial Managers to ensure compliance with regulatory guidelines and company SOPs Serve as a key team member for assigned clinical studies Provide administrative support by handling invoices, tracking metrics, and managing issues with contract service providers Participate in study team meetings, tracking study issues, and assisting with recruitment efforts Collaborate within clinical operations to document standard processes across clinical programs Develop relationships with investigator sites, IRBs/IECs, and CROs to meet trial requirements Coordinate essential document collection and IRB/IEC submissions, ensuring compliance throughout trials Facilitate study start-up processes and resolving quality issues with documents Support study monitors with document updates and addressing related questions Ensure eTMF documents are organized according to SOPs, policies, and standards Perform eTMF QC or Inspection Readiness QC and documenting findings for resolution Additional duties as assigned to contribute to the success of clinical trials Requirements: BS/BA in Scientific field or equivalent and 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred OR Master's degree in Scientific field or equivalent and some experience as noted above Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out. Some trial management protocol and process knowledge General understanding of Clinical Research industry and the relevant environments in which it operates Ability to plan activities and works well under changing circumstances; manages time effectively Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines Works to improve tools and processes within functional area Ability to work as part of a team Strong computer skills Good communications, problem-solving, analytical thinking skills Sees impact on department Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency Developing project management skills Ability at analyzing data and information to derive options/recommendations for management considerations #LI-SA1 Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $88,000.00-$127,550.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications • Bachelor's Degree Degree in scientific discipline or health care preferred. • Equivalent combination of education, training and experience may be accepted in lieu of degree. • Some organizations require completion of CRA training program or prior monitoring experience. • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). • Good therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). • Written and verbal communication skills including good command of English language. • Organizational and problem-solving skills. • Effective time and financial management skills. • Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Clinical Research Associate Job Location: Carlsbad Responsibilities: Clinical trial design in partnership with Director of Clinical Research and the Clinical team. Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines. Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines. Assists with the development and approval of clinical trial documents. Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity. Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory. Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol. Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies. Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials. Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals. Build positive relationships with clinical trial investigators and their research team. Coordinate and oversee other key research studies/activities as requested by the Director of Research. Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team. Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims. Requirements: Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred. 3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology. Experience working with industry sponsored clinical trials. Experience working in cosmetic and medical dermatology preferred. Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team. Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously. Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously. Ability to problem solve and troubleshoot challenges in a timely manner. General knowledge of current dermatological device systems, instruments, and products preferred. Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools. Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team. Ability to communicate effectively both verbally, and in writing. Ability to create professional reports, presentations, and reporting. Dedication and embodiment of our core values. Must possess a valid driver's license. 15% travel may be required. Physical Requirements: Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel. This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad. Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits. Ability to lift up to 15 lbs.

The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o Mission: Improving Lives by Providing Advanced Therapeutic Options o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research. o Values: o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Why this Role Exists The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values. Responsibilities -Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements -Bachelor's degree and 2 years relevant experience in the life science industry OR -Associate's degree with 4 years relevant experience in the life science industry OR -High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year -Clinical Research Coordinator experience -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens -Proficient ability to work independently, plan and prioritize with minimal guidance -Excellent attention to detail, organization, and communication with varied stakeholders -Ability to work as a team player with the ability to adapt to changing schedules and assignments Travel Requirements Daily commute to site(s) Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.