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The full-time Clinical Research Coordinator lI works closely with the Manager of Clinical Research in the
Department of Anesthesiology and coordinates all aspects of the department’s research component.
Serves as study coordinator for research protocols and QA projects as assigned. Activities include and are
not limited to recruiting patients to enroll in studies, obtaining informed consent, coordinating patient visits,
managing patient visits in accordance with protocol, submitting necessary compliance paperwork, and
billing compliance.
Duties Include:
Selects and recruits study participants to enroll in various studies and protocols; participates in the
informed consent process of study subjects; supports the safety of clinical research patients/research
participants; coordinates protocol-related research procedures, study visits, and follow-up care; screens,
completes case report forms (paper & electronic data capture), and addresses queries. Documents
investigational product (drug/device) accountability.
Maintains and creates study source documents and electronic databases; reports adverse events;
understands Good Clinical Practice (GCP) and regulatory compliance; educates subjects and family on
protocols, study interventions, study drugs, etc.; complies with institutional policies, standard operating
procedures (SOPs), and guidelines. Must comply with federal, state, and sponsor policies and manage
essential regulatory documents. Acts as a liaison for research subject, investigator, IRB, sponsor, and
healthcare professionals.
Instructs healthcare team personnel (nurses, technicians, and students) regarding equipment
operation, monitoring procedures, and patient care details associated with clinical studies. Develops
in-service education programs as needed for clinical research. Develops advertisement materials. Aids in
managing research volunteers involved their research projects.
Summarizes conditions of patients and fills out data collection forms, which involves explaining
procedures, protocols, and patient condition to patients and families.
Researches regulatory compliance participation in activities to initiate and maintain a current
regulatory file; prepares and submits documents related to research protocols to both internal (UF-IRB,
UF-CTC office, UF-OCR, etc.) and external (FDA, WIRB, etc.) organizations as required; completes
end-of-study procedures; schedules and participates in sponsored research monitoring visits and QA
audits; ensures the integrity and quality of the research protocol is maintained and the trial is conducted in
accordance with GCP guidelines; attends UF-IRB 01 full board meetings as necessary. Manages study
finances including sponsor invoicing and resolving study subject billing issues, participates in the
development, and conduct of study billing plans. Aids in clinicaltrials.gov submissions.
Prepares progress reports; periodically reviews study protocols and suggests changes as needed.
Reviews research projects periodically to ensure all procedures and aspects comply with nursing standards
and policies. Promotes Human Subjects Protections within clinical research areas
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