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Inside Higher Ed · 6 days ago

Clinical Research Program Director

Tallahassee, FL

Full-time

Onsite

Lead/Staff, Director/Executive

4+ years exp

Florida State University is one of the nation's elite research universities, and they are seeking a Clinical Research Program Director to manage and implement strategic initiatives supporting clinical and health research. The role involves providing guidance, resources, and training to investigators while ensuring compliance with regulatory requirements and promoting interdisciplinary collaboration.

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Responsibilities

Manage and contribute to the implementation of strategic initiatives supporting clinical and health research at FSU

Coordinate and provide tools, guidance, and resources to help investigators successfully navigate the full lifecycle of a study

Serve 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

Provide mentoring and guidance to staff and study teams on clinical research best practices, patient safety, and GCP-aligned procedures

Facilitate researcher understanding and application of regulatory requirements, including (but not limited to) the institutional review board and ClinicalTrials.gov registration and reporting

Serve as a liaison for FSU Health Research Connections, helping researchers navigate institutional resources, tools, and services

Respond to research support requests and coordinate support across administrative units

Support onboarding and engagement of investigators and study team members across departments, promoting interdisciplinary collaboration

Assist with tracking support requests and identifying gaps in service

Coordinate and participate in training and orientation activities for new research personnel to ensure compliance with University and federal standards for human subjects research

Direct the day-to-day operations of the Clinical Research & Trials Unit (CRTU) and other clinical research settings to ensure effective and compliant study conduct

Coordinate investigator use of the facility, supplies, and staffing, including scheduling, resource allocation, and adherence to established operating procedures

Implement and update SOPs governing facility use, researcher onboarding, biospecimen collection and storage, study coordination, documentation, and supply management

Provide clinical oversight for procedures within scope of licensure and ensure that study-related clinical activities are conducted safely and in accordance with institutional and regulatory requirements

Supervise assigned staff, ensuring adequate training, scheduling, and workload distribution to support ongoing studies

Foster professional development of clinical research coordinators, clinical research nurses, and OPS personnel by identifying opportunities for skill advancement and continuing education

Communicate with principal investigators (PIs) and study teams regarding ClinicalTrials.gov registration and reporting requirements

Review records in the Protocol Registration and Results System (PRS) to identify errors, missing, or outdated information

Notify researchers of non-compliance and collaborate with institutional compliance leadership to enforce local, state, and federal policies related to clinical trial transparency and reporting

Maintain 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

Monitor and communicate updates to relevant stakeholders, assisting in the interpretation of new or revised requirements

Implement strategies to promote compliance and continuous improvement within the FSU clinical and health research community

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

Participate in program planning, assessment, and evaluation to identify opportunities for improvement in research support services

Contribute to the development of new tools and resources that enhance efficiency, compliance, and collaboration across FSU’s clinical and health research programs

Participate in or lead campus-wide training sessions to strengthen research staff competency in clinical procedures, documentation standards, and participant safety

Perform other duties as assigned

Qualification

Clinical research experienceSupervisory experienceRegulationsClinical facility operationsResearch methodologiesTraining program developmentCommunication skillsProblem-solving skillsCustomer service skillsAnalytical skillsBiospecimen managementEHR systems proficiencyGCP guidelines proficiencyBLS certificationCCRPCCRC certificationOrganizational skillsCollaboration skillsCommitment to confidentiality

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)