Clinical Research Associate Jobs in Bonita, CA

The Clinical Trial Manager (CTM) oversees the execution of clinical trials, ensuring data accuracy, protocol adherence, and timely study completion. This role involves coordinating with internal and external teams to drive the successful progression of studies. Key Responsibilities: Manage clinical studies across all phases of development. Contribute to the creation of key study documents (protocols, ICFs, CRFs, etc.). Develop recruitment and retention strategies for study participants. Oversee study document management, including regulatory and insurance requirements. Create training materials for teams, sites, and vendors. Share key study information with stakeholders through reports. Ensure compliance with ICH/GCP and relevant regulations. Assist with RFPs and vendor/CRO selection. Draft and negotiate contracts with vendors and sites. Collaborate with Regulatory Affairs to ensure GCP compliance. Identify risks and implement mitigation strategies. Develop and maintain study plans with clear objectives. Supervise daily tasks and team development. Perform other duties as needed. Qualifications: Bachelor's degree in a scientific field or equivalent experience. 7+ years of clinical operations experience, with 2+ years in a supervisory role. Experience in early-phase studies is preferred. Ability to travel up to 5% of the time. Proficiency with Microsoft Office, TMF systems, CTMS, IRT, and EDC. Strong knowledge of the drug development process and regulatory requirements. Excellent communication and decision-making skills. Ability to manage data flow and generate reports. Experience in early-phase clinical trials is preferred. Lab Experience: Experience in biological or chemical laboratory environments, with adherence to safety standards. **Competitive Salary**

At SMSbiotech, we are at the forefront of regenerative stem cell therapies. Our mission is to democratize the application of adult stem cell technologies for human health. We foster a collaborative and dynamic environment where innovation thrives, and every team member plays a crucial role in our success. Position Overview: SMSbiotech seeks a highly motivated and detail-oriented Clinical Trial Specialist to join our expanding clinical operations team. The ideal candidate will be instrumental in ensuring the smooth execution and management of our clinical trials, working collaboratively across internal departments and external partners. This role requires a proactive individual with a strong understanding of clinical trial processes, regulatory guidelines, and a passion for advancing medical research. Key Responsibilities: Trial Coordination and Management: Oversee the day-to-day operations of assigned clinical trials, ensuring adherence to study protocols, timelines, and budgets. Maintain accurate and up-to-date trial documentation, including study protocols, informed consent forms, and regulatory submissions. Track and manage study supplies, including investigational products, ensuring proper storage and distribution. Monitor trial progress, identify potential issues, and proactively implement solutions to maintain study timelines. Cross-Functional Collaboration: Serve as a primary point of contact for internal departments (e.g., medical affairs, data management, regulatory affairs) and external partners (e.g., CROs, investigational sites). Facilitate effective communication and collaboration among all stakeholders to ensure seamless trial execution. Coordinate and participate in investigator meetings, site initiation visits, and monitoring visits. Regulatory Compliance: Ensure compliance with all applicable regulatory guidelines (e.g., GCP, ICH) and company SOPs. Assist in the preparation and submission of regulatory documents to relevant authorities. Maintain a thorough understanding of current regulatory requirements and industry best practices. Data Management and Reporting: Monitor data quality and integrity, ensuring accurate and timely data entry. Assist in the preparation of study reports and presentations. Assist in the management of Trial Master File. Site Management: Assist in the qualification, initiation, and closeout of clinical trial sites. Monitor site performance and address any issues that may arise. Assist with on-site monitoring, if needed. Travel: Willingness and ability to travel domestically and internationally as required for site visits, investigator meetings, and conferences. Qualifications: Bachelor's degree or higher in a life science field (e.g., biology, chemistry, nursing, or related discipline). Understanding of GCP, ICH guidelines, and regulatory requirements. Excellent organizational, communication, and interpersonal skills. Proficiency in using clinical trial management systems (CTMS) and other relevant software. Ability to work independently and as part of a team in a fast-paced environment. Strong problem-solving skills. Ability to manage multiple projects and priorities. Benefits: SMSbiotech offers a competitive compensation and benefits package, including health insurance (employee plan covered 100% by SMSbiotech), vision (employee covered), dental insurance (employee covered), and a 401k (SMSbiotech invests 3% of your annual pay) SMSbiotech is an Equal Opportunity Employer. This job advertisement aims to attract qualified candidates passionate about contributing to advancing medical research.

Barrington James is working with an exciting client who is a site network located in Oceanside, CA. Our client would like to find someone who has around 4 years of CRC experience working in the oncology and vaccine space. They would like to add someone who has a strong background working on Vaccine and Oncology Trials. Our client is a growing network and this allows plenty of opportunity for growth from with in. They are looking for someone with a passion in clinical research that they can grow with and around. Key Highlights: Onsite in Oceanside, CA. Oncology and Vaccine experience. 4 plus years of CRC experience. Future growth expected.

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 $42.02 - $57.51. 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.

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 *******************************************************

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

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

Computer Technologies Consultants (CTC) is seeking a part-time Clinical Research Data Developer/Manager to support the Defense Health Agency (DHA) in San Diego, CA. This will be onsite at the Naval Medical Center San Diego! With offices in Washington DC and San Diego, CA, CTC is a leading technology company providing lifecycle IT, data analytics, cloud managed hosting services, agile software development, DevOps, Test Automation, Cyber Security, and infrastructure solutions. Additionally, we provide Professional Talent Acquisition Services as we proudly support the unique needs of U.S. Defense, Intelligence, and Federal Civilian agencies as well as Fortune 1000 companies. Got the Government Contractor Blues? Looking for a company that cares and goes beyond just filling another contract billet? Well look no further! Experience this family-oriented company who takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with our client you have the opportunity to take on new and evolving challenges, aim beyond what you think you are capable of and work in collaborative, dynamic, and high-tempo environments. Our clients' employees are their most valued asset and they invest in their people because they are in it for the long term. They are committed to your success and well-being and offer competitive benefits packages, salaries, bonus/award programs, and a high potential for professional growth and job opportunities world-wide. Position Title: Clinical Research Data Developer/Manager Position Location: San Diego, CA (onsite) Daily Responsibilities: Manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Standardizes data management procedures and documents departmental operating procedures. Prepare data analysis listings and activity, performance, or progress reports. Process clinical data including receipt, entry, verification, or filing of information. Prepare appropriate formatting to datasets as requested. Design, manage, and validate clinical databases and large data repositories including designing or testing logic checks. Design forms for receiving, processing, and tracking data. Develop or select specific software programs for various research scenarios. Write work instruction manuals, data capture guidelines, or standard operating procedures. Train staff on technical procedures or software program usage. Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices. Provide support and information to functional areas as related to research. Evaluate processes and technologies and suggest revisions to increase productivity and efficiency. Develop technical specifications for data management programming and communicate needs to information technology staff. Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other documentation. Monitor work productivity or quality to ensure compliance with standard operating procedures. Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems. Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols. Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and workflow processes. Compile NMCSD clinical data from a variety of sources. Required Years of Experience (min): 2+ years of data developing/managing experience. Required Degree: Four-year baccalaureate degree is required health informatics, computer science, computer engineering, statistics, business administration, or equivalent field Required Experience: Preferred and Critical: Extensive experience in the NDR (National Data Repository) - requires specialized knowledge and how to pull the data. Methodical and strategic thinking. Project management skills. Strong writing skills. Computer literacy. Excellent communication skills, both verbal and written. Ability to meet deadlines Required Clearance: Candidates must be able to secure and maintain Tier 3 Non-Critical Sensitive security clearance Pay Information Hourly: $30/hr.-$60/hr. Please note: This range is based on our market pay structures. However, individual salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience. Computer Technologies Consultants, Inc. is an Equal Opportunity Employer that provides employment opportunities for all qualified applicants without regard to race, color, religion, gender identity and/or expression, sexual orientation, age, mental or sensory differing abilities, protected veteran status, sex, national origin, or any other characteristic protected by applicable law. Computer Technologies Consultants, Inc. is devoted to diversity, equity, and inclusion.

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 $42.02 - $57.51. 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 Optionso 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.

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, Monday through Friday in Torrey Pines. 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? At Scripps, we're interested in people who are interested in new possibilities. * Nearly a quarter of our employees have been with Scripps Health for over 10 years. * We treat one-quarter of the approximately 3.3 million people who live in San Diego County. * Our cardiovascular care, oncology, orthopedics, and other specialties have been nationally recognized. Why join this team? Scripps Health is committed to providing the best possible patient care, and research is a critical part of that mission. In addition to bringing the latest treatments to our patients, the knowledge gained from these research studies advances the quality of care for people around the world. The Clinical Research Services team is responsible for feasibility and research coordination for all clinical trials across all specialties. Our research team is growing and we are excited to be part of progressive clinical trials that will contribute and assist our patients in living their best lives. The Clinical Research Assistant will join our cardiology team. This position is ideal for someone who is a fast learner, interested in research and experienced with patient care. Responsibilities include: * Support trial coordinators in cardiology, with the opportunity to assist in other care areas. * Primarily focus on data entry, patient follow up visits and phone calls. * Coordinate multiple aspects of clinical trials and other human research ensuring compliance with research protocol and IRB requirements. * Manages regulatory documents and data submission, assists with IRB submissions, responsible for keeping internal data tracking systems up-to-date. * Provide 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. Required Certification/Registration: * BLS Preferred Education/Experience/Specialized Skills/Certification: * BS/BA. * Proficiency in medical terminology * Research experience * Cardiology 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

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.

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug. Maintains accurate source documents related to all research procedures. Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. Schedules and participates in monitoring and auditing activities. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Requirements: High School Diploma/GED 1 year Clinical research related experience #Jobs-Indeed Req ID : 1690 Working Title : Clinical Research Coordinator I, SLASH (Onsite) Department : Cancer - SOCCI Clinical Research Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $23.39 - $39.76

Job Description: 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.

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 ******************************************************* 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.

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 Optionso 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: Clinical Research CoordinatorCompany: Profound ResearchLocation: Oceanside, CA 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 RequirementsDaily 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.