About This Role
Coordinating and performing daily clinical research activities for sponsor-initiated trials in the Department of Psychiatry is the core of this role. The coordinator will recruit, interview, and enroll patients, ensuring compliance with regulatory and sponsor requirements throughout the consent process and study visits.
Responsibilities
- Implement, coordinate, and perform daily clinical research activities in accordance with active clinical trial protocols
- Assist with assessing patient records to identify eligible participants for specified clinical research protocols
- Recruit, interview, and enroll patients
- Obtain informed consent and ensure the consent process is administered in compliance with regulatory and sponsor requirements
- Educate patients and families on the purpose, goals, and processes of clinical study
- Ensure initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol
- Coordinate scheduling and follow-through of surgeries, medical procedures, and other diagnostic testing
- Collect and document medical histories
- Prepare and conduct study visits, participating in the collection, processing, and evaluation of vital signs and biological samples
- Coordinate and document care of patients
- Assist with monitoring patients for adverse reactions to study treatment, procedure, or medication and notify appropriate clinical professional to evaluate patient response and identify status of complications
- Document unfavorable responses and notify research sponsors and applicable regulatory agencies
- Participate in evaluating patients for compliance related to protocol
- Assist with collecting clinical research data
- Compile and enter clinical research data into study database
- Prepare and submit regulatory documents to applicable governing agency related to the conduct of human subject research
- Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations
- Assist with coordinating and preparing for external quality assurance and control reviews by IRB, federal, or industry sponsors
- Participate in planning, organizing, and preparing for external quality assurance and control reviews by IRB, federal, or industry sponsors
- Complete case report forms
- Attend departmental meetings
- Attend investigator meetings
Requirements
- Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences, or other medical field, or equivalent combination of education and experience
