Clinical Research Coordinator III
Palo Alto Veterans Institute for Research (PAVIR) is looking for a Clinical Research Coordinator to manage all aspects of assigned clinical studies including recruitment, enrollment, collection procedures, and data analysis. The Clinical Research Coordinator will work independently and serve as a role model to other study coordinators.
ABOUT THIS ROLE
This position will support public health and infectious diseases clinical research at the VA Palo Alto Health Care System (VAPAHCS), working closely with the Principal Investigator - Dr. Mark Holodniy, Professor of Medicine - Infectious Diseases at VAPAHCS, who holds an academic appointment with Stanford University.
The Clinical Research Coordinator in Dr. Holodniy's research laboratory will liaise between the PI, Stanford IRB, patients, VAPAHCS clinical staff, VA R&D, PAVIR, Study Sponsors, and ORO, and update data regarding the study in various databases and reporting structures. This Research Coordinator is also expected to support other study coordinators assigned to PI's current and potentially new studies.
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 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
Administrative Study Planning Tasks:
- Plan, coordinate and facilitate ALL research activities related to assigned studies;
- Review all contracts and agreements associated with studies;
- Review and administer study budgets associated with investigations;
- 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.
Ongoing Study Patient Related Activities:
- 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;
- Consent subjects according to ICH Guidelines;
- Act as a liaison between the study subject, the PI, the Study Sponsor, the IRB and the VA R&D, concerning any problems or adverse reactions/events related to study procedures;
- Perform and label sample / specimen collection according to protocols; prepare samples for shipment to reference laboratories as required;
- Perform EKGs and vital signs as needed.
Other Study Management Activities:
- 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;
- Meet with the sponsor's study monitor to ensure data quality and integrity before database lock and transfer;
- Respond to site clarification queries via data clarification form(s);
- Contribute to the production of publications for studies;
- Support other study coordinators within PI's current studies for coverage.
QUALIFICATIONS FOR A CLINICAL RESEARCH COORDINATOR
- Bachelor's degree (or equivalent experience) in Health or Biological Sciences or a related field;
- 5 years of experience as a clinical research coordinator in a complex clinical and research environment;
- 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;
- Strong knowledge of SAS;
- Proficiency with computers and database management;
- Previous experience with CTMS, EDC, and other electronic case report forms;
- Proven track record towards meeting goals and deadlines;
- Proficiency with Microsoft Word, Excel and PowerPoint.
- Master's degree in biological sciences, healthcare, or in a related field;
- 10 years of experience in clinical research in public health and/or infectious diseases;
- CCRC or CCRA is desired;
- Experience with VA CPRS highly desired;
Environmental Conditions: Exposure to office, clinical, and laboratory environments. Potential exposure to blood borne pathogens.
READY TO JOIN OUR RESEARCH TEAM?
If you feel that you would be right for this job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you!
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 email@example.com - Human Resources department.
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