Clinical Research Coordinator II
Palo Alto Veterans Institute for Research (PAVIR) is looking for a Clinical Research Coordinator to support the clinical research of the VA Palo Alto Health Care System (VAPAHCS) by assisting with the implementation of all new and ongoing studies. The Research Coordinator will have a key role in supporting and expanding different aspects of the clinical research program, which includes facilitating clinical trials from inception, implementation, and closeout.
ABOUT THIS ROLE
The Research Coordinator will report to PAVIR's Senior Clinical Research Program Manager and serve under the guidance/direction of VAPAHCS Principal Investigators (PIs) from different therapeutic areas. This position will be exposed to all aspects of clinical operations of exciting studies taking place at the VA hospital in Palo Alto. The Clinical Research Coordinator plays a critical role at every stage of clinical studies and will have the opportunity to grow in the clinical research field. The Research Coordinator would be expected to be on-site as needed, e.g. for on-site patient visits, etc., however, working from home is also an option as work schedule allows.
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
Pre-Study Activities:
- Administratively and clinically manage an average of four to eight clinical trials.
- Perform pre-study feasibility assessment and study kick-off meeting.
- Serve as primary contact for sponsors and triage as appropriate.
- Serve as a resource / trainer to other incoming study coordinators as needed.
- Complete all aspects of clinical trial registration.
- Assist with initial patient recruitment strategy and prepare associated materials for IRB submission.
- Coordinate and implement procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostics tests, and other sources.
Study Start Up:
- Coordinate collection of study documents; Schedule and attend Pre-Site Selection Visits and Site Initiation Visits.
- Submit IRB submissions and coordinate responses to IRB queries.
- Discuss study protocols with patients.
- Recruit, obtain informed consent, screen and enroll patient research subjects in eligible clinical trials. Review of Medical History of patients against Inclusion/Exclusion Criteria.
- Set up subject reimbursement processes.
- Manage coordination and logistics of receiving and shipping of study materials from and to the sponsor.
Study Maintenance:
- Serve as a primary contact of the study team.
- Schedule patient visits. Performs Patient Visit Reminders, Visit Confirmations and/or Rescheduling of Visits.
- Ensure protocol adherence.
- Ensure that adverse events are properly documented and reported as per protocol.
- Dispense study medication following protocol requirements.
- Screen and file laboratory results.
- Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
- Schedule and set up monitoring visits.
- Complete Case Report Forms and address all queries as generated by the monitor.
Regulatory and Compliance:
- Review protocols and ensure compliance with the requirements of the protocol, regulatory agencies, HIPAA, ICH/GCP guidelines, and institutional policies of the VA and Stanford.
- Report any protocol violation/deviation to the Sponsor, IRB, and Regulatory Authorities.
- Assist PI in the initiation and renewal of IRB and R&D Committee Submissions.
- Ensure the filing and maintenance of all regulatory documents.
- Prepare Investigator Site Files and subject charts for internal and external audits.
Study Closeout:
- Coordinate the study Close Out Visit with the sponsor.
- Manage tasks related to pharmacy and laboratory closeout activities including reconciliation of study drug and temperature logs, shipment of unused collection kits.
- Closeout the IRB, R&D, and PAVIR accounting.
QUALIFICATIONS FOR A CLINICAL RESEARCH COORDINATOR
- Bachelor's degree (or equivalent experience).
- Two years of research-related experience with coordination of clinical trials involving human participants.
- Experience in conduct of oncology-related trials is highly desired.
- Certificate (or equivalent) in clinical trials education course(s) is desired.
- Ability to effectively present information and respond to questions from sponsor/CRO, physicians, staff and patients.
- Knowledge of the Principles of Good Clinical Practice (GCP), HIPAA, Bloodborne Pathogens, International Air Transport Association (IATA).
- Knowledge of IRB, FDA, and other regulatory requirements.
- Knowledge of EMR systems.
- Ability to prioritize and organize a high-volume workload and adapt to changing priorities.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to work independently.
- Proficient with Microsoft applications (Word, Excel, PowerPoint, and Outlook).
- Knowledge of VA's health care system regarding clinical research trials is desired.
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 jobs@pavir.org - Human Resources department.
Location: 94304
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For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.