Northern California HERC

Palo Alto Veterans Institute for Research (PAVIR) is seeking a full-time Clinical Research Assistant to work under the guidance/direction of VAPAHCS Principal Investigator (PI) - Dr. Minal Vasanawala - while supporting different aspects of the clinical research program in Nuclear Medicine Service, which includes facilitating clinical trials from inception to closeout.

The Clinical Research Assistant position will assist with the implementation of all new and ongoing studies. The Research Assistant will play a critical role at every stage of clinical studies and will have the opportunity to grow in the clinical research field.

Successful completion of the U.S. Department of Veterans Affairs (VA) security clearance process is required for this position. The clearance process typically takes approximately 2–3 months, though timelines may vary depending on individual circumstances and processing volume. The selected candidate must successfully complete this clearance process before they are able to begin employment in the position.

BENEFITS

PAVIR is delighted to offer a robust and comprehensive employee benefits package with exceptional offerings such as health, dental and vision insurance, 14 paid holidays, generous vacation and sick pay policies, 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.

MAIN RESPONSIBILITIES:

• Assist with managing administratively and clinically an average of two to three clinical trials.
• Support completion and coordination of 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.
• Create initial patient recruitment strategy and prepare associated materials for IRB submission for approval.
• Assist with collection of study documents (e.g. protocol signature pages, Form 1572, PI CVs)
• Schedule and attend Pre-Site Selection Visits and Site Initiation Visits with Sponsor.
• Receive sponsor-specific training for Electronic Data Capture (EDC) system(s) and other study-specific training, as needed.
• 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.
• Support coordination and logistics of receiving and shipping of study materials.
• Act as a primary contact for the study team for designated project communications, and associated documentation.
• 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.
• Practice protocol adherence: understand, communicate, and ensure study parameters are ordered and carried out per protocol requirements.
• Practice 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.
• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
• 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 (COV) with the sponsor.
• Prepare the EDC system for data lock.
• Manage tasks related to pharmacy and laboratory closeout activities including reconciliation of study drug and temperature logs, return of study equipment as required.
• Close out the IRB, VA R&D, and PAVIR accounting.
• Responsible for study record archival and tracking of materials as per protocol.
• Maintain internal processes and participate in department activities and process improvement activities as appropriate.
• Contribute and help maintain Standard Operating Procedures for department and position.
• Other related duties as needed.

QUALIFICATIONS:

• Required: Bachelor's degree or equivalent experience is required;
• At least 0-2 years of relevant clinical trial/ clinical research experience.
• Desired:
• Experience with human participants, maintaining clinical trial regulatory compliance, and data collection;
• Certificate (or equivalent) in clinical trials education course(s);
• Experience in conduct of oncology-related trials;
• Ability to read, analyze, and interpret information from industry-sponsored clinical trial protocols, technical procedures, or governmental regulations is preferred;
• Ability to effectively present information and respond to questions from sponsor/CRO, physicians, staff and patients is desired;
• Knowledge of following: Principles of Good Clinical Practice (GCP), HIPAA, Bloodborne Pathogens, International Air Transport Association (IATA) is preferred;
• Knowledge of IRB, FDA, and other regulatory requirements is desired;
• Knowledge of Electronic Medical Record systems is desired;
• Ability to prioritize and organize a high-volume workload and adapt to changing priorities is preferred;
• Familiarity with standard concepts, practices, and procedures within the clinical research field is desired;
• Excellent interpersonal, verbal, and written communication skills;
• Ability to work independently;
• Proficiency with Microsoft applications (Word, Excel, and Outlook);
• Knowledge of VA and its health care system regarding clinical research trials and understanding of VA procedures and safety issues, desired.

ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR)

PAVIR engages in the administration of funds and providing support for the conduct of 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.

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 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 jobs@pavir.org - Human Resources