Clinical Research Coordinator

Responsibilities

• Prepare all relevant Institutional Review Board (IRB) paperwork (e.g., initial review documents, study renewals/closure reports, adverse events, study modifications, etc.).
• Review, edit, and format all research protocols and consent documents before submitting all materials through CyberIRB.
• Obtain informed consent; review information with subjects; conduct follow-up calls; assess and advocate for patient safety throughout each protocol procedure.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Act as liaison between departments, stakeholders, and UCSF.
• Respond to queries from the IRB in a timely manner.

Data Management

• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Maintain electronic study records and regulatory study binders.
• Maintain research log in Microsoft Excel of all ongoing projects in Emergency Medicine.
• Work with study PIs to ensure compliance with clinical protocols and federal guidelines.
• Maintain records of Human Subjects Protection Training for all personnel involved in departmental research studies.

Staff, Research Associates, and Volunteer Training and Coordination

• Help train staff, research associates/volunteers, and others on new research protocols, research fundamentals, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
• Aid in the development and updates to a curriculum for volunteer research associates that covers clinical research fundamentals.
• Support the research director with the selection, training, and utilization of volunteer research associates.
• Help the research director guide research associates/volunteers in developing study proposals.
• Aid in scheduling a multi-disciplinary team of lecturers who can speak to volunteers about their specific department’s role.
• Maintain training tools and quizzes to help the research director assess research associates’/volunteers’ knowledge.
• Coordinate mock consent trainings to ensure research assistants can appropriately and effectively interact with patients.
• Submit grades as provided by the research director, to Fresno State for students receiving credit for volunteer work.
• Cook up shifts, shadowing shifts, and EMS ride-a-longs for research associates/volunteers.

Study Implementation

• Create advertisements, reminders, and procedural documents for each study and ensure their proper application.
• Submit data request forms, operational feasibility applications, and study protocols to appropriate departments.
• Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
• Ensure study folders contain plenty of data collection sheets for active subject enrollment.
• Collect and store study data inside UCSF Fresno’s Clinical Research Center.
• Ensure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.

Grants and Contracts

• Track expenditures for grants.
• Submit annual reports to funding agencies.
• Aid in grant proposal writing, editing, and submissions.

General Assigned Duties

• Facilitate investigator meetings and conference calls as needed.
• Maintain a tracking log of Emergency Medicine residents’ research requirements.
• Prepare and submit abstracts to national meetings.
• Serve as a contact for research volunteers, rotating medical students, and pre-med students.
• Perform literature reviews as necessary.