Clinical Research Coordinator - Interventional Oncology Trials
Palo Alto Veterans Institute for Research (PAVIR) supports the nation's second largest research program in the VA system and is looking for a Clinical Research Coordinator to support interventional clinical trials.
The ideal candidate will have experience in conduct of oncology-related trials since the Research Coordinator will support studies evaluating therapies for lung cancer and/or therapies for prostate cancer. If the selected candidate can only work part-time, that would be acceptable, but we will also consider applicants who are seeking a full-time opportunity.
ABOUT THIS ROLE
The Research Coordinator will work on-site at the VA Hospital in Palo Alto, CA, while supporting different aspects of the clinical research program, which includes facilitating clinical trials from inception to closeout.
The Research Coordinator will work under the guidance and direction of VA Principal Investigators (PIs), most of whom maintain academic appointments with Stanford University.
The Research Coordinator will be exposed to industry sponsors, will have direct interaction with prestigious Principal Investigators from different therapeutic areas, and will be exposed to all aspects of clinical operations of exciting studies taking place at the VA Palo Alto.
PAVIR offers generous benefits, including comprehensive health insurance, vision, dental, 14 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.
JOB RESPONSIBILITIES OF A CLINICAL RESEARCH COORDINATOR
Study Start Up:
- Administratively and clinically manage an average of four to six clinical trials.
- Complete and coordinate study specific VA and IRB regulatory and compliance tasks to support rapid start up.
- Serve as primary contact for sponsors on administrative and regulatory issues.
- Assist with initial patient recruitment strategy and prepare associated materials for IRB submission.
- Coordinate collection of study documents; Schedule and attend Pre-Site Selection Visits and Site Initiation Visits.
- Draft and finalize Informed Consent Form, in collaboration with PI and sponsor.
- Set up subject reimbursement processes, based upon protocol and ICF requirements.
- Collaborate with VA ancillary departments (e.g. Lab Services, Radiology) to ensure processes are set up to meet requirements of study protocol.
- Manage coordination and logistics of receiving and shipping of study materials.
- Serve as a primary contact of the study team.
- Recruit, obtain informed consent, screen and enroll patient research subjects in eligible clinical trials. Review of Medical History of patients against Inclusion/Exclusion Criteria requirements.
- Ensure protocol adherence and that non-serious and serious adverse events are properly documented and reported as per protocol.
- Screen all laboratory results and follow protocol procedure regarding abnormal results.
- Obtain, process and ship required specimens per protocol.
- Obtain all required source documentation, create original source documents as required.
- Schedule and facilitate monitoring visits as required by sponsor/CRO.
- Complete Case Report Forms (CRFs) and address all queries as generated by the monitor.
- Maintain Investigator Site Files for monitoring visits, final reconciliation and archival.
- Report any protocol violation/deviation to the Sponsor, IRB & Regulatory Authorities per protocol requirements.
- Assist PI in the initiation and renewal of IRB and R&D Committee Submissions.
- 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.
- Closeout the IRB, VA R&D, and PAVIR accounting.
QUALIFICATIONS FOR A CLINICAL RESEARCH COORDINATOR
- Bachelor's degree or equivalent experience.
- Relevant experience in research setting, including subject recruitment and screening.
- Experience with maintaining regulatory compliance and data collection.
- Experience in conduct of oncology-related trials strongly preferred.
- 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) and HIPAA.
- Knowledge of IRB, FDA, and other regulatory requirements.
- 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.
- Proficiency with Microsoft applications (Word, Excel, and Outlook).
- Certificate (or equivalent) in clinical trials education course(s) is desired.
- Knowledge of Bloodborne Pathogens and International Air Transport Association (IATA).
- Knowledge of EMR systems.
- Knowledge of VA's health care system regarding clinical research trials is desired.
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 and recruit talented employees who believe in making a difference in the lives of others through innovative health research.
As a condition of employment, all PAVIR employees are required to have an approved appointment with VA and complete a background check before they can commence work.
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 go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.