Clinical Research Associate II

The Palo Alto Veterans Institute for Research (PAVIR) is seeking a Clinical Research Associate to coordinate and conduct research studies under the supervision of the Principal Investigator (PI) and VA Polytrauma Systems of Care (PSC) Research and Leadership team, which includes the Headache Center of Excellence, and Physical Medicine and Rehabilitation service.  The primary research study is a longitudinal study of the effects of traumatic brain injury.  Other studies involve epidemiology, neuroimaging, neurostimulation, proteomics, genetics, cognition and other demographic variables that are important to assess, manage and treat patients with Traumatic Brain Injury (TBI).

About This Role

The Research Associate will participate in all aspects of research including study participants screening, recruitment, contact and interview, data entry and quality control, statistical data analysis, required regulatory affairs and compliance, study organization, literature reviews and reporting.  In addition, this position may have the opportunity to develop research materials and contribute to manuscript development and publication.  The Research Associate will have the opportunity to travel and be involved at a national level with other researchers.  Other programmatic activities to support the leadership and TBI programs will include workshop planning, recruitment, coordinating with clinical and research staff, and various other administrative duties.

This position is Federally funded and requires US citizenship.

About PAVIR

PAVIR, located on the premises of the VA Palo Alto Health Care System, is a mid-size nonprofit foundation, closely connected with the VA and Stanford University. We offer ongoing training, generous benefits and supportive work environment. We work with more than 160 uniquely talented medical scientists across a broad spectrum of research areas. We recruit talented employees who believe in making a difference in the lives of others through innovative research.

This is a full time, Exempt (Salary-paid) position. Location: Palo Alto, CA. Benefits:

• Medical, Vision and Dental Insurance
• Vacation
• Sick Pay
• 13 paid Holidays
• Life Insurance - paid by PAVIR
• Long-term and Short-term Disability Insurance - paid by PAVIR
• Flexible Spending Account
• 401(k) Retirement Plan with Company Match and Profit Share
• Wellness Program
• Employee Assistance Program
• Commuter Benefit

PAVIR is 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.

Duties and Responsibilities

Research Implementation and Database Management:

• Create, collect, disseminate, and maintain appropriate files of study data. Assist with review and completion of study manuals and SOPs;
• Communicate with participants to perform data collection, consenting, scheduling, testing, evaluation, and assessments. Conduct assessments with research participants using research tools in person, by mail or phone. Track and monitor the participants requirements for study schedule;
• Extract data from patient medical records. Transcribe and resolve data queries in case report forms
• Facilitate data quality assurance mechanisms and participant communication;
• Prepare documents, under the direction of project leaders. Report statistical analyses and descriptive data from associated research studies to be used in research/clinical investigations/studies reports;
• Maintain study related documents and supplies. Secure, organize, and document as required all federal/ state regulations and national multi-site policies;
• Contribute to PSC research programs that align with national, regional, and local missions and goals;
• Contribute to the planning and execution of the research conferences.

Regulatory Study Management:

• Prepare technical documentation necessary for regulatory submissions related to research;
• Develop and maintain other technical documentation required for compliance, such as research protocols, policies, consent forms, CV/ biosketches, and annual reports;
• Interface with research team to ensure proper coordination of regulatory strategy and timelines necessary to meet regulatory requirements;
• Participate in proactive and continuous improvements for regulatory affairs and in support of research quality;
• Report study progress, status, and adherence with requirements to stakeholders (e.g., VA Central Office, National Data Statistical Center, funding bodies).

Programmatic and Research Development:

• Assist and support innovative research areas within the fields such as assistive technology, TBI, and headache;
• Support, organize, implement and maintain protocol development;
• Interface with research team to ensure proper coordination of timelines necessary;
• Participate in proactive and continuous improvements for program and research areas;
• Report study progress, status, and adherence with requirements to stakeholders (e.g., VA Central Office, National Data Statistical Center, funding bodies).

Administrative Duties:

• Act as point of contact for monthly meetings;
• Manage Time cards for staff members;
• Attend clinical care and leadership meetings as required to support the research and programs;
• Contribute to project teams as applicable;
• Undergo trainings related to research. Train other research support staff in general research duties, such as data entry, CPRS, and administrative oversight within VA.