Clinical Research Program Director

Job Title:

Clinical Research Program Director

Tallahassee, FL

Regular

Full-Time

61816

The Clinical Research Hub within the Division of Research seeks to fill the Clinical Research Program Director position. (Use the "Apply for this Job" box below)./

This position will manage and contribute to the implementation of strategic initiatives supporting clinical and health research rdinates and provides tools, guidance, and resources to help investigators successfully navigate the full lifecycle of a study. Serves within the Clinical Research Hub as a subject matter expert, developing and managing the delivery of clinical and health research education, training materials, user guides, special events, and learning opportunities for the research community.

Provides mentoring and guidance to staff and study teams on clinical research best practices, patient safety, and GCP-aligned procedures. Facilitates researcher understanding and application of regulatory requirements, including (but not limited to) the institutional review board and Clinical Trials.gov registration and reporting.

Will be responsible for serving as a liaison for FSU Health Research Connections, helping researchers navigate institutional resources, tools, and services. Responds to research support requests and coordinates support across administrative units. Supports onboarding and engagement of investigators and study team members across departments, promoting interdisciplinary collaboration. Assists with tracking support requests and identifying gaps in service. Coordinates and participates in training and orientation activities for new research personnel to ensure compliance with University and federal standards for human subjects research.

Directs the day-to-day operations of the Clinical Research & Trials Unit (CRTU) and other clinical research settings to ensure effective and compliant study conduct. Coordinates investigator use of the facility, supplies, and staffing, including scheduling, resource allocation, and adherence to established operating procedures. Implements and updates SOPs governing facility use, researcher onboarding, biospecimen collection and storage, study coordination, documentation, and supply management.

Provides clinical oversight for procedures within scope of licensure and ensures that study‑related clinical activities are conducted safely and in accordance with institutional and regulatory requirements. Supervises assigned staff, ensuring adequate training, scheduling, and workload distribution to support ongoing studies. Fosters professional development of clinical research coordinators, clinical research nurses, and OPS personnel by identifying opportunities for skill advancement and continuing education.

In conjunction with the Clinical Research Hub Director, communicates with principal investigators (PIs) and study teams regarding Clinical Trials.gov registration and reporting requirements. Reviews records in the Protocol Registration and Results System (PRS) to identify errors, missing, or outdated information. Notifies researchers of non‑compliance and collaborates with institutional compliance leadership to enforce local, state, and federal policies related to clinical trial transparency and reporting.

Maintains current knowledge of federal and state regulations governing human subjects research, clinical research, and data privacy, including the Common Rule, FDA, GCP, HIPAA, and HITECH. Monitors and communicates updates to relevant stakeholders, assisting in the interpretation of new or revised requirements. Implements strategies to promote compliance and continuous improvement within the FSU clinical and health research community.

Will collaborate with internal and external stakeholders, including University leadership, faculty, students, staff, and community healthcare partners, to support and implement initiatives that strengthen the research enterprise. Participates in program planning, assessment, and evaluation to identify opportunities for improvement in research support services. Contributes to the development of new tools and…