Staff Research Associate IV (Clinical Research Coordinator)

$66,560 - $105,464/Yr

Veterans Health Research Institute - San Francisco, CA

San Francisco, CA

Religious, Grantmaking, Civic, Professional, and Similar Organizations

About the position

The Clinical Research Coordinator (CRC) will be responsible for providing clinical and administrative support to the Principal Investigator (PI) for a variety of research studies conducted in the SFVAHCS Cardiac Catheterization Laboratory (CCL). Responsible for performing clinical research activities as delegated by the Principal Investigator within appropriate scope of practice. Ensure conduct of study activities according to study specific protocols, governmental regulations, GCP guidelines and local site SOPs. The CRC will be responsible for the coordination of one or more clinical studies or clinical trials; help prepare protocols for study initiation; help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding participants; apply understanding of inclusion/exclusion eligibility criteria for protocols; help screen, recruit, enroll, consent, register, schedule and retain participants; record protocol specific treatments and assure collection, processing, and shipment of samples; assist research personnel to keep participants on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings including occasional travel to study-related meetings; and perform other duties as assigned.

Responsibilities

• Contributes to planning and organizing the clinical aspects of the research studies.
• Identify and coordinate with interdisciplinary departments involved with the implementation of the clinical study.
• Prepares and manages IRB submissions and reports.
• Maintain regulatory documents in compliance according to Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) procedures.
• Responsible for screening subjects to evaluate subjects' records to determine eligibility according to the protocol's criteria.
• Conducts the informed consent process and ensure all aspects of the process are met.
• Collects clinical data required by the study protocol.
• Maintain complete and accurate case report forms and source documentation for each subject enrolled.
• Documents all significant study patient encounters in CPRS.
• Communication of all protocol-related issues/problems to the PI and the sponsor.
• Ensures that Study Drug or Device administration is completed per protocol.
• Coordinates and participates in meetings, conferences, training sessions and other forums regarding the conduct of the clinical study.
• Prepares and participates in quality assurance activities.
• Ensure that all VA sensitive information is being used, stored and secured in accordance with the VHA policies and guidance.
• Assists PI with reimbursement submissions.
• Maintains files documenting research trainings, credentials, research-related TMS certificates, CVs, licensing, certifications, memberships, and other related materials for each study team member.
• Maintaining accurate and detailed records of research activities, including data collection and analysis.
• Scheduling of study sessions, meetings, phone calls, etc.
• Screen potential study participants, obtain informed consent from study participants, explain study procedures to participants, and run study participants in IRB-approved studies.
• Creating study materials.
• Assisting with literature reviews.
• Assisting with manuscript preparation.
• Assisting with budget planning, negotiation, and contracting with sponsors.
• Maintaining reliable and regular contact with faculty, and keep PI apprised of study updates.
• Mentoring and training junior staff members, students, and interns in clinical research protocols.
• Keeping abreast of new developments and advances in their field and incorporating this knowledge into their work.
• Collaborating with other clinical research coordinators and Principal Investigators.
• Interacting with funding agencies, regulatory agencies, and other stakeholders to ensure compliance with all relevant regulations and standards.
• Performing other related duties as assigned.

Requirements

• Ph.D or similar with 7-8 years of relevant experience and/or RN with significant clinical research experience.
• Previous experience in coordinating and conducting clinical research studies.
• Knowledge of the code of federal regulations for conducting clinical research, GCP guidelines and SOPs.
• Knowledge of IRS / SFVAMC R&D regulations and reporting requirements.
• Experience with conducting the research consent process and documentation and HIPAA regulations.
• Experience working with diverse teams of interdisciplinary administrators and clinicians.
• Ability to conduct and manage multiple projects, tasks and priorities.
• Required to have and maintain documentation of annual training in ethics of human subject research and GCPs.
• Ability to work under minimal supervision.
• Strong accuracy and attention to detail.
• General project management skills.
• Excellent verbal and written communications and presentation skills.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment.

Benefits

• Base salary range of $66,560.00 - $105,464.32 per year.
• Eligibility to earn additional compensation including bonuses.