Senior Clinical Research Associate Jobs Near Me

Entry Level Hybrid Research Coordinator Role in Chicago, IL (60612) We are hiring for an entry level Research Coordinator to join an exciting research site in the Chicagoland area. This position will be a 2 year long contract. Overall we are looking for a candidate that has some exposure to the research field that is passionate about making a positive impact as a Research Coordinator. Responsibilities: Communicate with patients Obtain required information and medical history Ensure patients have filled out the Online Questionnaire Data Collection Regulatory Responsibilities - Communicating with the IRB, attending meetings, providing data, etc. Confirming patients appointments/Assisting in scheduling patients Attend foundation meetings Ensure everyone on site is up to speed Additional Responsibilities as needed Details: Location: Chicago, IL (60612) Title: Research Coordinator Pay: $20/hr-$24/hr Hours: Monday-Friday; 9AM-4PM; Some flexibility to work remote Contract: 2 Year long contract

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for Freelance Clinical Research Associates to work on a study in Finland. The project will be approximately 0.5 FTE. Candidates with infectious disease experience is preferred. Join our team and help us deliver clinical trials that will improve patients' lives. Main Job Tasks and Responsibilities: Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites. May act as Feasibility Associate after appropriate and documented training. Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance. Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety. Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data. Manages the investigational products (storage, inventory, dispensing records, packaging, and labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site. Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues. Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. You will be the main contact person for the site in order to ensure close follow up. Provides general support to the Clinical Research Division on quality control of clinical data. Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned. Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial. Develops training material and gives training in collaboration with the Training & Qualification Management Unit. May assist in contract negotiation with sites on study budget after appropriate and documented training. Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites. May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training. Education and Experience: University Degree in scientific medical or paramedical disciplines. Previous proven experience as a CRA, performing on-site monitoring activities. Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements. Experience with infectious disease studies is preferred. Specific Role Requirements and Skills: Fluent in English and Finnish. Proficiency in Microsoft Office (e.g. Word, Excel, Outlook). Willingness to travel. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Site Management, Monitor, Monitoring, Complex Trials, Infectious Disease, Travel, Submissions, Ethics, Contract Research Organisation, CRO #LI-VH1 #LI-REMOTE #SENIOR #Part Time

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Organizational Overview: Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease. The Role: In collaboration with a therapeutic area VP of Clinical Development, the Clinical Research Scientist (CRS) will contribute to the design, conduct, analysis, and reporting of clinical trials. The CRS will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery to supporting the registration and commercialization of a product. Key Responsibilities: Contribute to the review, interpretation, and communication of scientific data pertaining to the efficacy and safety of compounds in development Effectively collaborate with the VP clinical development, the clinical trial manager and the clinical operations manager on all aspects of clinical study development from start to finish Attend congresses and review literature to develop and augment expertise in their specific therapeutic area Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Review competitive landscape and help identify and evaluate business development opportunities Have responsibility for providing focused scientific and clinical study support from start-up to clinical study report (CSR) and publications. Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to the program Engage opinion leader interactions to build pipeline awareness and foster research collaborations Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage assets Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings Requirements: Advanced degree in Sciences required (e.g. M.S., PharmD, PhD or equivalent) PhD, PharmD or equivalent and 7+ years of clinical trial experience in the pharmaceutical industry is preferred. (M.S. and 10 years of experience as a CRS in pharmaceutical industry) Ability to provide input and direction to clinical research with appropriate supervision Strong desire to collaborate in a cross-functional setting Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols Work Environment: Dynamic, interactive, fast-paced, and entrepreneurial environment Immunovant' s headquarters is located in New York City. The position is flexible for remote work. Domestic travel required (up to 10%) Salary range for posting$220,000—$230,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Piper Companies is seeking a Clinical Research Associate (CRA) to join a global leader in clinical research and healthcare analysis for a remote position. The Clinical Research Associate (CRA) will monitor and participate in clinical trials across the country for a leading Clinical Research Organization. Responsibilities of the Clinical Research Associate include: * Conduct site monitoring visits to ensure compliance with GCP, ICH, and regulatory guidelines. * Support subject recruitment and adapt recruitment plans as needed. * Provide protocol training and manage communication with study sites. * Assess site adherence to protocol and regulatory requirements, reporting quality issues. * Track study progress, including regulatory approvals, enrollment, data collection, and query resolution. * Maintain accurate site documentation, including visit reports and regulatory files. Qualifications for the Clinical Research Associate include: * At least 2 years of onsite oncology monitoring experience * Proficiency in CTMS, EDC, and Microsoft Office Suite. * Strong knowledge of GCP, ICH guidelines, and regulatory requirements. * Experience in site management, patient recruitment, and clinical trial documentation. * Strong therapeutic and protocol knowledge in Phase 1 oncology trials. * Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred). Compensation for the Clinical Research Associate: * Salary Range: $90,000-$120,000 * Comprehensive Benefits: Medical (Cigna), Dental (Guardian), Vision (VSP), sick leave if required by law, and 401K (Voya through ADP) This job opens for applications on 2/28. Applications for this job will be accepted for at least 30 days from the posting date.

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leader in clinical research, is seeking a full-time Clinical Research Associate (CRA) Team Lead, to oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies. This person will need to live within a few hours of our Tempe, Arizona location. Essential FunctionsTeam Leadership and Line ManagementProvide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies This includes, but is not limited to:•Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations.•Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure that staff has the proper materials, systems access and training to complete job responsibilities.•Prepare and implement function specific training programs; ensure training on and adherence to Celerion's procedures and guidance documents, best business practices, legal and confidentiality constraints.•Assign staff members to clinical projects, monitor staff workload, and liaise with the Manager of Monitoring, GCD North America (as needed) to ensure appropriate allocation of resources and optimal utilization.•Ensure timely submission of timesheets and expense reports by staff as well as review/approve timesheets and expense reports in a timely manner.•Develop, mentor, manage and coach CRA staff to progress their skills so that the organization's quality standards are maintained.•Perform annual appraisals, define the performance objectives and advocate individual career development, responsibility and accountability•Serve as escalation line for direct reports, including trouble shooting, issue escalation, deviation management, QI/CAPA management•Advocate for the needs of the staff with other functions of the organization•Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high quality delivery of individual/team/departmental goals•Maintain a positive, results oriented work environment, build partnerships, model teamwork, and communicate in an open, balanced, and objective manner•Contribute to Process Improvement initiatives for Line of Service (LOS) Project related responsibilities Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations. This includes, but is not limited to:•Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows: -Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs -Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.) -Co-monitor as needed -Update and review of clinical trial management tracking systems (CTMS) -Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened) -Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors -Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan•Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary;•Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues•Participate and demonstrate proactive involvement in project study meetings, internal project study meetings, and other activities enhancing project progress•Participate in audits and inspections, including preparation and follow-up activities as needed•Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements.•May act as a CRA for selected studies where needed and defined Additional Responsibilities•Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client•Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)•Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities•Maintain a working knowledge of all required Celerion IT systems•Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary•Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates•Perform other duties as assigned Requirements and Qualifications:•Bachelor's degree in a biomedical-related field, life sciences or equivalent field;•At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience•People Management skills preferred;•Excellent oral and written communication skills in English;•High level of organization, multi-tasking, judgement , and analytical skills;•Good time management skills to ensure adherence to timelines;•Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements ;•Dedication to quality and reliability;•Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research;•Ability to work well independently and as part of a team;•Self-motivation;•Maintain confidentiality of Subject data and Sponsor/Client information•Computer literate;•Strong attention to detail while being tactful and diplomatic.•Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements;•Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits and in maintaining Trial Master Files and handling SAEs;•Flexible and willing to drive to the Tempe, Arizona site without much advanced notice. Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Join our CRA Team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! MEDPACE CRA TRAINING PROGRAM (PACE ) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: * PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. * PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. * To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus; * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check; * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE ); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or life science related field; * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary ABOUT ALIRA HEALTH At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client's organization from concept ideation to commercial realization; from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services. Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada. Job Description THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel. ESSENTIAL JOB FUNCTIONS* • Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc. • Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs • Responds to sites' regulatory board requests for protocol and ICF clarification as needed • Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment • Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews • Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites • Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests • Conducts remote review of data entered on electronic Case Report Forms (eCRFs) • Works closely with field CRAs and data management to resolve queries on discrepant data • Assists with efforts to recruit investigative sites to participate in clinical studies • Complies with ICH GCP guidelines, FDA regulations, and company SOPs • Participates in internal, client/sponsor, scientific, and other meetings as required • Manages and resolves conflicting priorities to deliver on commitments Performs additional duties as assigned PREPARATION, KNOWLEDGE, SKILLS & ABILITIES • BS/BA from an undergraduate program or equivalent experience • 1-2 years of experience in clinical research • Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Self-starter who thrives in a collaborative, yet less structured team environment • Ability to problem-solve unstructured or ambiguous challenges • Strong command of English, both written and verbal • Excellent communication and interpersonal skills with customer service orientation • Proficient with MS Office Suite, particularly Word and Excel • Permanent authorization to work in the U.S. WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs. Languages English Education Bachelor of Arts (BA), Bachelor of Science (BS) Contract Type Regular

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: • Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations • Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits for studies of all phases in a range of different indications. • Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans • Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process • Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs) • Assist in preparing sites for audits, review audit reports and contributes to resolve findings • Build and maintain solid and long-term professional relationships with investigators and site staff Qualifications You are: • BA/BS/BSc degree or similar • Familiarity with ICH/GCP guidelines plus local codes of practice as applicable • Experience or Training working as a CRA • Proficiency in English and German • Willingness to travel • Good working knowledge of common software packages • Flexibility and Team skills What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary We are seeking a Lead Clinical Research Associate (LCRA) to oversee in-house Oversight CRAs that will oversee CRO CRA's management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee's primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity. Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The LCRA has ‘in-house' responsibilities (e.g., oversight CRAs), and as required by project scope, performs sponsor monitoring or co-monitoring visits at the clinical study sites. The LCRA collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives. Key Responsibilities In-house responsibilities The Lead CRA is responsible for the study deliverables of in-house CRAs on a given study(s), ensuring study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements May be responsible for the hiring of in-house CRAs Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms) Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools) Support the training and development of in-house CRAs and ensuring study training compliance is maintained Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery Oversight of review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed Responsible for oversight of CRA review of clinical data (e.g. electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site's data with quality and integrity Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations Support and liaise with clinical site personnel, as needed Review and approve time sheets and expense reports Assist with review and revision of departmental SOPs and policies Assist with creation and deliver new department initiatives, improvement plans or training May assist with the identification and selection of appropriate clinical trial sites and investigators Field monitoring responsibilities Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites' compliance with study timelines, protocol requirements, and applicable regulatory guidelines Review and ensure data integrity, accuracy, and completeness at the clinical study sites Escalate site related issues to the study team Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed Ideal Candidate Bachelor's degree in a scientific or healthcare-related field Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry Minimum 2 years of experience leading a team of CRAs Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus Certification as a Clinical Research Associate (CCRA) or equivalent preferred Recent experience working on trials utilizing risk-based monitoring models Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems Strong understanding of clinical trial processes and study conduct Excellent organizational and time management skills Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight Experience working in a fast-paced and dynamic environment Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires approximately 35% travel including travel to company meetings at least twice per year The anticipated salary range for candidates for this role will be $135,000 - $170,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here

Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Clinical Study Manager could be an exciting opportunity to explore. A Clinical Study Manager provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries: across all therapy areas to the required quality standards, GSK written standards, local regulations and ICH GCP. Additionally, you will provide operational support to the Global Medical Sciences team within the business and provide flexible operational support within various functions across Global Medical Sciences. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Leads the local study team consisting of within-country clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the country/countries. Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies). Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, Vaccines, and local SOPs and POLs. Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders. Identifies and resolves or escalate risks and issues that may impact study delivery. Provides feedback on performance, capabilities and competencies of study members to line management. As required, reviews and approves monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan. Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility. As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites. As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study. Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within country/countries, local treatment/immunization guidelines and local health care system requirements. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree 5 or more years of industry project management experience Experience providing operational support across global scientific and medical functions. Experience with phase I-IV of the clinical trial Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Degree in Life Sciences Strong stakeholder management experience Proven ability to influence and build consensus #LI-GSK The annual base salary for new hires in this position ranges from $112,500 to $187,500 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at ************** (US Toll Free) or *************** (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

The Clinical Research Nurse serves as a clinical research expert and administrative liaison in the Institute for Clinical and Translational Science Clinical Research Unit. Applies clinical skills requiring specialized licensing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. Provides professional nursing care, monitor patients within a defined outpatient and/or inpatient setting, and conduct clinical research within parameters of study protocols following established standards and practices. Participate in protocol review, cost analysis, and QA. Incorporates human subjects' protection, care coordination and continuity, and contribution to clinical science and clinical practice. Duties to include but not limited to: Clinically assess the participant's health status by gathering information and identifying actual and potential health problems. Implement the clinical research protocol according to established standards and participant care priorities. Acquire working knowledge of all current and proposed research projects. Collect accurate data as specified per protocol. Assure data collection procedures are in adherence with the assigned study protocol and in accordance with good clinical practice. Monitor compliance of regulatory guidelines. Manage safety of participants. Provide supervision over functional support staff. Participate in trainings and workshops to keep informed on topics related to clinical research. For a full job description, please send an e-mail to the contact listed below. About ICTS: The Institute for Clinical and Translational Science (ICTS) at the University of Iowa was approved by the Iowa Board of Regents in 2007 to support the work of investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, to promote engagement of community members and other stakeholders, to promote research integration across the lifespan, and to catalyze innovative clinical and translational research. These efforts will lead to the development of novel therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and, ultimately to measurable improvements in the health of Iowa and the nation. Percent of Time: 100% Pay Grade: 5A **************************************** Benefits Highlights: -Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans -For more information about Why Iowa?, click here Required Qualifications Graduation from an accredited RN Program, with a Master's degree in nursing, preferred, supplemented by one or more years of progressively responsible nursing experience or an equivalent combination of education and experience. A current license to practice professional nursing in the state of Iowa is required by the date of hire. 1-3 years recent experience (within the past 5 years) caring for patients in an acute care setting. Strong clinical nursing skills including IV insertion, phlebotomy, and assessment is required. General computer skills are required including MS Word and Outlook. Excellent written and verbal communication skills are required including positive interpersonal skills as demonstrated through written and verbal interactions. Ability to work independently. Excellent time-management skills and the ability to accurately perform detail-oriented work. Requires the ability to work some weekends, evenings, and nights. Desirable Qualifications Working knowledge of Good Clinical Practice (GCP). Good clinical practice (GCP) is the ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Minimum of 1-year chemotherapy infusions experience. Knowledge of clinical research process. Experience with Epic. Application Process: In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission: Resume Cover Letter Job openings are posted for a minimum of 14 calendar days and may be removed from positing and filled any time after the original posting period has ended. Successful candidates will be required to self -disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.Hybrid within Iowa: This position is eligible for a combination of on-campus and remote work. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies. Remote within Iowa: This position is eligible for primarily remote work but may require limited work onsite at times. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies. As previously discussed, this position is eligible for hybrid work within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location. For additional questions, please contact Amy Stewart at ********************* This position is not eligible for University sponsorship for employment authorization. Additional Information Compensation Contact Information

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. Remote opportunity, but must be central or east coast based and near a major airport as this role requires significant travel. SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: Purpose-Driven: We are purpose-driven in a tireless pursuit of our mission for patients. Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. Team Players: We roll-up our sleeves and work together as one team to achieve our goals. Key Responsibilities: The Clinical Research Associate (CRA) plays a key role in the lifecycle of SI-BONE's clinical studies. The CRA manages clinical study sites and coordinates activities to ensure overall compliance with the protocol and clinical objectives. This includes clinical site monitoring, both remote and onsite, the goal of which is to ensure high-quality study data and maintain good site relations. The CRA is expected to maintain a high level of professional expertise by reading relevant literature, attending meetings, and collaborating with physician customers. The CRA is responsible for performing all duties in compliance with all applicable corporate policies and worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual. The employee must act and conduct company business in an honest, ethical and lawful manner, consistent with the company's policies and AdvaMed Code of Conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Specific Responsibilities: Conducts site qualification, initiation, interim monitoring, and close out visits. Ensures high-quality data through remote and onsite monitoring, acting as the study protocol expert and key resource for site staff, while guiding them and resolving queries within agreed timelines. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciling it with the Trial Master File (TMF), and ensuring the site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Actively manages site compliance with the protocol including enrollment, follow up visits, timely and accurate data entry through frequent site review and communication. Contributes to the preparation of study related documents including CRFs, ICF, clinical monitoring plan. Understands therapeutic area for assigned clinical projects. Supports the SI-BONE Quality System, adheres to company policies, and performs mandated trainings on time. Knowledge, Education and Experience: Knowledge of medical terminology Strong problem-solving skills Basic understanding of summary statistics Agile and able to change direction as needed Ability to identify and solve problems independently 2+ years clinical research experience, or advanced degree with experience working with nurses and physicians Bachelor's degree in health science field preferred Travel fluency Expertise and Attributes: Self-starter is a must for this position Friendly outgoing personality who can build trust and rapport with physicians and study coordinators Organized and efficient, this person should be a true team player with excellent verbal and written communication skills. Writing sample (monitoring report and follow up letter) required for review Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971, ISO 14155) as required to perform the job function Salary range: $73,000 - $81,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit ********************** We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain “@si-bone.com” to communicate with candidates. If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at *************************************************** learn how to report it.

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. Remote opportunity, but must be central or east coast based and near a major airport as this role requires significant travel. SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: * Purpose-Driven: We are purpose-driven in a tireless pursuit of our mission for patients. * Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. * Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. * Team Players: We roll-up our sleeves and work together as one team to achieve our goals. Key Responsibilities: The Clinical Research Associate (CRA) plays a key role in the lifecycle of SI-BONE's clinical studies. The CRA manages clinical study sites and coordinates activities to ensure overall compliance with the protocol and clinical objectives. This includes clinical site monitoring, both remote and onsite, the goal of which is to ensure high-quality study data and maintain good site relations. The CRA is expected to maintain a high level of professional expertise by reading relevant literature, attending meetings, and collaborating with physician customers. The CRA is responsible for performing all duties in compliance with all applicable corporate policies and worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual. The employee must act and conduct company business in an honest, ethical and lawful manner, consistent with the company's policies and AdvaMed Code of Conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Specific Responsibilities: * Conducts site qualification, initiation, interim monitoring, and close out visits. * Ensures high-quality data through remote and onsite monitoring, acting as the study protocol expert and key resource for site staff, while guiding them and resolving queries within agreed timelines. * Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciling it with the Trial Master File (TMF), and ensuring the site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. * Actively manages site compliance with the protocol including enrollment, follow up visits, timely and accurate data entry through frequent site review and communication. * Contributes to the preparation of study related documents including CRFs, ICF, clinical monitoring plan. * Understands therapeutic area for assigned clinical projects. * Supports the SI-BONE Quality System, adheres to company policies, and performs mandated trainings on time. Knowledge, Education and Experience: * Knowledge of medical terminology * Strong problem-solving skills * Basic understanding of summary statistics * Agile and able to change direction as needed * Ability to identify and solve problems independently * 2+ years clinical research experience, or advanced degree with experience working with nurses and physicians * Bachelor's degree in health science field preferred * Travel fluency Expertise and Attributes: * Self-starter is a must for this position * Friendly outgoing personality who can build trust and rapport with physicians and study coordinators * Organized and efficient, this person should be a true team player with excellent verbal and written communication skills. Writing sample (monitoring report and follow up letter) required for review * Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971, ISO 14155) as required to perform the job function Salary range: $73,000 - $81,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit ********************** We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain "@si-bone.com" to communicate with candidates. If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at *************************************************** learn how to report it.

Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience Remote Clinical Research Associate III requires: Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm EST Qualifications: BS/BA Minimum of 2 years of site management and field monitoring experience Knowledge of applicable standards and regulations for clinical trials Proven oral and written communication skills Proven planning skills; ability to create and track detailed project plans Proven interpersonal, leadership, organizational and effective time management skills Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion Preferred: Experience in womens fertility VD Study Experience Medidata RAVE system Remote Clinical Research Associate III duties: Performs Site initiation, interim & close out monitoring visits Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete Manages site communication and escalates to leadership in a timely fashion when needed Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings

Job Title: Senior Clinical Trial Specialist (Remote) Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Employer Industry: Medical Device and Clinical Research Why Consider This Job Opportunity Salary up to $186,700 plus bonus eligible and benefits Opportunity for career advancement and growth within the organization Work remotely anywhere within the United States, with a preference for Eastern time zone Supportive and collaborative work environment Chance to make a positive impact on patient outcomes in the field of stroke therapies What To Expect (Job Responsibilities) Provide high-quality site monitoring and management for the Study Operations team within Clinical Shared Services Proactively communicate with investigators, colleagues, and vendors to ensure clinical quality and compliance Conduct clinical research activities in accordance with applicable regulations and guidelines Manage overall clinical site activities and provide oversight to Clinical Research Associates (CRAs) Develop and implement enrollment and recruitment strategies for clinical studies What Is Required (Qualifications) Bachelor's Degree in a health/science field (RN, BSN, MBBS, DPharm) 4 years of industry experience in a clinical study operations role within Medical Device or Pharma 3 years of independent site management responsibilities and data monitoring experience Demonstrated independence in conducting Site Qualification and Site Initiation Visits Working knowledge of GCP/ICH guidelines and federal/local regulations How To Stand Out (Preferred Qualifications) Master's, MBA, or PhD Experience performing Site Close-Out Visits ACRP CCRA Certification or SOCRA CCRP Category 3 Certification Medical Device monitoring experience Global clinical trial experience and EUMDR working knowledge #MedicalDevices #ClinicalResearch #RemoteWork #CareerOpportunity #CompetitivePay Talentify helps candidates around the world to discover and stay focused on the jobs they want until they can complete a full application in the hiring company career page/ATS. Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. For more details and to find similar roles, please check out the below Lifelancer link. **********************/jobs/view/310c8bd348198d1e464de6f77dd1258c

Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve. At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply. Job Summary The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate/Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements. The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. Qualifications PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties will be performed under general supervision by the Clinical Research Manager. The following clinical duties will be performed: * Assist clinical team in screening potential patients for study participation * Schedule all protocol required tests and procedures * Coordinate patient appointments with physicians, nurses, and all test areas * Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers * Prepare pre-visit communication for providers to ensure required assessments are completed and documented * Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation * Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition * Coordinate, obtain, process, and ship protocol required tissue samples * Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL) * Obtain vital signs and perform EKGs as required for individual studies * Administer quality of life assessments as required for individual studies The following data management responsibilities will be performed: * Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria * Enroll patients as required by the study sponsor and internal enrollment monitor team * Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance * Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. * Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations * Maintain research charts and/or electronic files for all enrolled patients * Ensure adequate source documentation is in place for all data reported * Resolve data queries issued by the sponsor * Obtain protocol clarifications from the study sponsor and communicate information to the research team * Schedule and prepare for monitoring visits with sponsors * Facilitate the request and shipment of archival pathology samples * Organize and prepare for internal and external audits * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs SKILLS/ABILITIES/COMPETENCIES REQUIRED: * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects' rights and individual needs LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable): * None Additional Job Details (if applicable) EDUCATION: * BA/BS degree required EXPERIENCE: * None SUPERVISORY RESPONSIBILITY (if applicable): supervised. * None FISCAL RESPONSIBILITY (if applicable): * None WORKING CONDITIONS: * Duties will be performed primarily on-site in ambulatory/clinical office setting * Components of the data/regulatory role may allow for remote work. Remote Type Onsite Work Location 55 Fruit Street EEO Statement: The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

Career CategoryClinicalJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Clinical Research Sr Medical Scientist, Endocrinology - US, Remote Live What you will do Let's do this. Let's change the world. In this vital role you will support the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan. Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the clinical development program. Participate and provide clinical input into safety and regulatory interactions. Provide clinical/scientific input during the development and execution clinical trials. Review data from clinical trials related to medical monitoring, as well as support and address questions from sites and from investigators. As needed, provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols). Interpret clinical trial data and participate in safety assessments. Review and provide clinical scientific input to safety narratives. Initiate database analyses to support commercial/clinical objectives. Contribute to the preparation of clinical study reports and regulatory submissions. Support interactions with regulatory agencies if needed. Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the GDL or delegee and help identify new clinical research opportunities. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications: Basic Qualifications: Doctorate degree and 2 years of experience in clinical trials implementation in obesity, diabetes, or metabolic diseases OR Master's degree and 4 years of experience in clinical trials implementation in in obesity, diabetes, or metabolic diseases OR Bachelor's degree and 6 years of experience in in clinical trials implementation in obesity, diabetes, or metabolic diseases OR Associate's degree and 10 years of experience in clinical trials implementation in obesity, diabetes, or metabolic diseases Preferred Qualifications: Accredited residency in Endocrinology, board certified or equivalent 2+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities MD preferred. Prior research in obesity, diabetes, or metabolic diseases preferred. An understanding of the scientific method and clinical applications based medical, scientific and practical rationale Familiarity with concepts of clinical research and clinical trial design and execution including biostatistics Familiarity with regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of solving problems, especially in implementation of clinical trials while exhibiting superior judgment and balanced, realistic understanding of issues. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $168,677. to $218,907. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #obesity . Salary Range 168,677.00 USD - 218,907.00 USD

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Hourly Rate: $20.00 - $22.00/hr Monday - Friday (AM Office Hours) Job Summary: Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines. SOPs (Standard Operating Procedures), ICH (International Council for Harmonization), GCP (Good Clinical Practices), and FDA (Food and Drug Administration). Essential Responsibilities and Duties: Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines. Uploads regulatory documents with RealTime eDOCs System and files is paper binders, as necessary. Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums. Tracks submissions and ensure timely filing of documents. Obtains CVs (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents. Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff. Assists in obtaining necessary signatures from investigators. Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues. Ensures Clinical Conductor regulatory information is current. Participates in team meetings and complies with training requirements. Assists sponsors/CRO's as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Minimum High School graduate or equivalent. Minimum of 1 years of related experience. Must be self-directed and able to work with minimal supervision. Able to take a flexible approach to shifting priorities. Motivated to work consistently in a fast paced and rapidly changing environment. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Ability to work overtime, weekends, and/or holidays as needed. Ability to travel as needed. Remote work arrangement depending on location. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.