Clinical Research Program Director

The Clinical Research Hub within the Division of Research seeks to fill the Clinical Research Program Director position. https://clinical.research.fsu.edu/

This position will manage and contribute to the implementation of strategic initiatives supporting clinical and health research at FSU. Coordinates 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 ClinicalTrials.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 ClinicalTrials.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 resources that enhance efficiency, compliance, and collaboration across FSU’s clinical and health research programs. Participates in or leads campus-wide training sessions to strengthen research staff competency in clinical procedures, documentation standards, and participant safety. Performs other duties as assigned.

Bachelor’s degree and six years of experience in a clinical research setting; or master’s degree and experience in the same field equal to four years.

• Must have two years in a supervisory role in a clinical setting.
• Valid driver’s license and access to reliable transportation for travel to study sites and related events.
• Comprehensive knowledge of federal, state, and institutional regulations governing clinical research (HIPAA, Common Rule, FDA, ClinicalTrials.gov).
• Demonstrated ability to interpret and apply research methodologies, principles, and best practices in clinical and health research settings.
• Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities.
• Excellent communication and customer service skills, with the ability to work collaboratively and professionally with research participants, investigators, healthcare providers, and administrative staff.
• Experience managing clinical facility operations, scheduling, and inventory, including biospecimen collection, processing, and storage.
• Demonstrated experience conducting or supporting FDA-regulated studies involving investigational drugs or devices and collaborating with industry sponsors or contract research organizations.
• Experience coordinating safety and compliance initiatives in partnership with institutional Environmental Health & Safety and Human Subjects Protection programs.
• Commitment to maintaining confidentiality, data integrity, and adherence to ethical standards in research.

• Current State of Florida (or compact) registered nurse (RN) license.
• Current basic life support (BLS) certification.
• Certified Clinical Research Professional (CCRP), ACRP Certified Professional (ACRP-CP), or Certified Clinical Research Coordinator (CCRC).
• Proficiency with Good Clinical Practice (GCP) guidelines and compliance processes.
• Experience developing or delivering clinical research training programs.
• Experience with EHR systems (e.g., Epic, Athena), electronic data capture platforms (e.g., REDCap, Qualtrics), and clinical trial management systems (e.g., OnCore, Veeva Systems)

Cassidy Cooksey at ccooksey@fsu.edu

One of the nation's elite research universities, Florida State University preserves, expands, and disseminates knowledge in the sciences, technology, arts, humanities, and professions, while embracing a philosophy of learning strongly rooted in the traditions of the liberal arts and critical thinking. Founded in 1851, Florida State University is the oldest continuous site of higher education in Florida. FSU is a community steeped in tradition that fosters research and encourages creativity. At FSU, there’s the excitement of being part of a vibrant academic and professional community, surrounded by people whose ideas are shaping tomorrow’s news!

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If qualified and interested in a specific job opening as advertised, apply to Florida State University at https://jobs.fsu.edu. If you are a current FSU employee, apply via myFSU > Self Service.

Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume.

This is an A&P position.

This position requires successful completion of a level 2 criminal history background check.

FSU is an Equal Employment Opportunity Employer.