Clinical Research Coordinator I

Summary

Coordinate all clinical research activities with moderate supervision; Expected to perform all Clinical Research Coordinator (CRC) Core responsibilities as listed below (as applicable).

Examples of Work

Job functions are specific duties that would be included in the essential functions of the job description.  These functions are not all-inclusive nor do they cover the full extent of the duties performed.

• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, study drug, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Must comply with federal, state, and sponsor policies
• Manage essential regulatory documents
• Assist with registration of the study in ClinicalTrial.gov database.
• Assist with management of study finances.
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, and monitoring visits
• Facilitate study close out activities
• Coordinate research/project team meetings
• Collect, process and ship laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Participates in promoting Human Subjects Protections within Clinical Research areas

Education and Experience

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

Licensure and Certification

For some positions assigned to this class, special qualifications may be added to the minimum, such as professional registration or certification, or medical credentials.

Supervision

This position does not typically have supervisory responsibility.

To see common career pathways for each position at the University of Florida please visit the Career Paths section of the UFHR website.