Clinical Research Coordinator - Cardiology Studies
Palo Alto Veterans Institute for Research (PAVIR) is looking for a full-time Clinical Research Coordinator to manage all aspects of assigned clinical studies including completing IRB forms, recruiting, and enrolling subjects, collecting procedural data, completing case report forms, and making follow-up phone calls.
ABOUT THIS RESEARCH COORDINATOR ROLE
The Research Coordinator will work on Cardiology studies, for example, catheterization lab studies comparing a new device to the standard of care. The Coordinator will report directly to the Principal Investigator - William Fearon, M.D., Professor of Medicine (Cardiovascular Medicine) at Stanford University Medical Center.
This a full-time position, located in Palo Alto, CA.
PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS and complete a background check before they can commence work.
PAVIR offers generous benefits, including comprehensive health insurance, vision, dental, 13 paid holidays, paid vacation time, sick pay, a 401(k) with a fully vested 6% company match and 3% profit share, a wellness program, commuter benefits, and professional development training. Plus, we pay for life, short-term disability, and long-term disability insurance.
ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR)
PAVIR engages in the administration of funds and providing support for the conduct of clinical research at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) to find new and improved ways to combat human disease and help people with disabilities. At PAVIR we work with more than 160 uniquely talented medical scientists.
Our researchers have an active appointment with the VA Palo Alto Health Care System and most maintain academic appointments with Stanford University. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research.
JOB RESPONSIBILITIES OF A CLINICAL RESEARCH COORDINATOR
- Recruit, screen, and interview study subjects.
- Plan, coordinate and facilitate all research activities related to assigned studies.
- Review and administer study budgets associated with investigations including all hospital impact sheets.
- Plan, coordinate, and facilitate research activities for potential new PI studies.
- Prepare, submit and maintain all required regulatory documents, including for any potential new studies to the appropriate institutions and databases.
- Prepare and submit all documentation required for FDA phase of the trial.
- Evaluate and analyze clinical data from medical records to determine initial eligibility of patients for participation in studies requiring HIPPA waivers.
- Communicate with study subjects, in writing and verbally, on all administrative aspects of the study.
- Explain the nature, purpose, and procedures of this investigation to potential participants in detail prior to consenting of subject.
- Assist in the preparation of IRB protocol submission and revisions.
- Report adverse events in a timely manner to study sponsor and IRB.
- Perform and label sample/specimen collection according to protocols; Prepare samples for shipment to reference laboratories as required.
- Collect all study data as required.
- Maintain and update all relevant databases, case report forms, and regulatory binders.
- Review, verify, and approve clinical study data prior to submission to the sponsor.
- Respond to site clarification queries via data clarification form(s).
- Support other study coordinators within PI's current studies for coverage.
QUALIFICATIONS FOR A CLINICAL RESEARCH COORDINATOR
- Bachelor's degree or equivalent experience;
- At least 1 year of related experience. This may include prior experience as a research coordinator, experience working with patients in a clinical setting, reporting adverse events, and/or subject recruitment;
- Excellent knowledge of study site perspective of Clinical Trials;
- Knowledgeable in GCP, US FDA regulations, and ICH guidelines;
- Good understanding of clinical terminology and procedures gained through experience;
- Demonstrated understanding of regulatory requirements regarding the clinical trial and IRB processes;
- Ability to read and understand study/trial protocol;
- Ability to lead and work on multiple projects and studies;
- Demonstrated understanding of Use of Human Subjects in Research requirements;
- Demonstrated ability to work independently and cooperatively;
- Demonstrated ability to work and communicate effectively with study subjects;
- Proficiency with computers and database management;
- Previous experience with CTMS, EDC, and other electronic case report forms;
- Knowledgeable, with an ability to explain to others, in VA regulations and policies pertaining to clinical trials;
- Proven track record towards meeting goals and deadlines;
- Proficiency with Microsoft Word, Excel and PowerPoint.
- Master's degree;
- 2 years or more of experience in clinical research in cardiology and, ideally, interventional cardiology;
- Experience in conduct of cardiology-related trials;
- CCRC or CCRA certification;
- Experience with VA CPRS.
Environmental Conditions: Exposure to office, clinical, and laboratory environments. Exposure to imaging equipment (i.e. Cardiac Cath Lab). Some exposure to bloodborne pathogens.
READY TO JOIN OUR RESEARCH TEAM? Please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you!
PAVIR engages in nonprofit medical research and works with sponsors and the Veterans Affairs Palo Alto Health Care System (VAPAHCS) in administering funds for conducting research to find new and improved ways to combat human disease and help people with disabilities. Please refer to our website for additional information: www.pavir.org
PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need special assistance or an accommodation to apply for a posted position, please contact firstname.lastname@example.org - Human Resources department.
For more information, or to apply now, you must click on the green Apply Externally button. Please DO NOT email your resume to us as we only accept applications through our website.