OPS - Clinical Research Coordinator I

Classification Title:

OPS - Clinical Research Coordinator I

Job Description:

The University of Florida College of Nursing is seeking a part-time (0.50 FTE - 20 hours per week) dedicated and detail-oriented Clinical Research Coordinator I (CRC I) to support daily oversight of operations for a large behavioral clinical trial for chronic musculoskeletal pain that includes IRB and regulatory compliance, serve as a liaison to various stakeholders including community-based organizational leaders and members, engage in community outreach activities for recruitment, enrollment and retention of eligible persons, resolution of technical issues, and project closeout activities.

Key Responsibilities:

• Oversee daily operations and workflow of a clinical trial at GNV and JAX sites- prepare study materials, participant screening, consent, scheduling, communication/follow-up, and compensation, lab compliance, maintenance of data management platforms, purchasing supplies and monitoring inventory, resolve technical issues, participate in weekly lab meetings. Ensures proper organization of study files, including but not limited to, regulatory binders, study specific source documentation and other materials by the research coordinator assigned to the investigation.

• Support community outreach and activities, participant recruitment and retention, serve as a liaison to community-based organization stakeholders. Provide weekly reports about recruiting and retention activities including issues encountered while trying to perform his/her duties in research team meetings. They will participate in problem-solving activities to adjust recruitment and retention strategies

• Follow an IRB approved protocol and train new research specialist and students on adhering to the approved IRB protocol emphasizing rigor in the informed consent process of study participants. Contributes to the promotion of Human Participant Protections at all points in the conduct of research.

• Prepare and submit documents to the IRB and Safety Officer. Manage essential regulatory documents for the research studies including federal, state, sponsor, UF policies, and standard operating procedures (SOPs) and training guidelines. Maintenance of templates and examples of essential documents frequently used in the preparation of a protocol i.e. informed consent, telephone script.

• Perform quality assurance ensuring proper maintenance of regulatory binder, protected health information and study documents. Coordinates internal audits as deemed appropriate.