Florida State University · 1 day ago
Clinical Research Program Director
Tallahassee, FL
Full-time
Onsite
Lead/Staff, Director/Executive
4+ years expFlorida State University is one of the nation's elite research universities, and they are seeking a Clinical Research Program Director to manage and contribute to strategic initiatives supporting clinical and health research. The role involves overseeing the implementation of research education, compliance with regulatory requirements, and fostering collaboration among researchers.
EducationUniversities
Responsibilities
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
Qualification
Required
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
Preferred
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)
Benefits
FSU offers a robust Total Rewards package.
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Company
Florida State University
Florida State University is an American public space-grant and sea-grant research uivnersity.
5001-10000 employees
H1B Sponsorship
Florida State University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (152)
2024 (108)
2023 (106)
2022 (80)
2021 (33)
2020 (34)
Funding
Current Stage
Late StageTotal Funding
$108.2MKey Investors
National Science FoundationNational Institutes of Health
2024-02-23Grant· $6M
2023-01-27Grant· $72.7M
2021-10-14Grant· $14.5M
Leadership Team
Ebe Randeree
Associate Dean. College of Communication & Information
Jeff Latimer
Director of IT for College of Medicine and FSU Health
Recent News
2025-11-24
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