Manager, Clinical Research

Job Description:

The Clinical Research Manager provides leadership and operational oversight for the Clinical Research Office (CRO) within the Office of Research Affairs (ORA) in Jacksonville. The Clinical Research Manager leads interdisciplinary research teams, oversees the planning and execution of clinical research studies, and ensures compliance with FDA regulations, institutional policies, and sponsor requirements. This position serves as a key point of contact for investigators, sponsors, and internal stakeholders, facilitating collaboration, problem-solving, and successful study execution throughout the research lifecycle. A core function of this role includes providing hands-on training in clinical trial implementation, as well as supporting and mentoring less experienced clinical research coordinators to enhance their skills, knowledge, and competency in clinical trial techniques and research operations. The Clinical Research Manager actively promotes staff development through structured training, ongoing coaching, and performance support to strengthen team capability and research quality. Additional responsibilities include supervising and mentoring clinical research staff; supporting professional development and training initiatives; and managing the administrative, operational, and financial aspects of the CRO. This role also contributes to the growth of clinical research programs by supporting study development, improving operational performance, and assisting with the identification of funding opportunities and external partnerships.
This position offers the opportunity to shape and expand clinical research operations, improve study performance, and support high-quality, patient-centered research in a collaborative academic healthcare environment. Clinical Research Office (CRO) Operations and Leadership Provide strategic leadership and operational oversight for the development, growth, and management of the Clinical Research Office (CRO). Apply advanced expertise in clinical research operations and services to strengthen infrastructure, improve efficiencies, and enhance CRO capabilities. Develop, implement, and monitor core operational functions that support continuous improvement, innovation, and high-quality research services. Supervise CRO personnel, allocate resources effectively, and align staffing and operational support to meet the needs of Jacksonville investigators and research teams, with the goal of increasing study volume, operational performance, and quality outcomes. Reconcile study payments via the university’s clinical research system. Prepare monthly reports outlining the financial status of studies, enrollment targets, etc. Training and Mentorship Deliver hands-on training in clinical trial implementation and provide ongoing support and mentorship to less experienced clinical research coordinators. Enhance team members’ skills, knowledge, and competency in clinical trial techniques, study operations, and regulatory compliance to strengthen overall clinical research capability. Research Administration and Study Support Oversee all levels of research administration, faculty support, and staffing related to CRO operations to ensure the timely execution of institutional and departmental directives. Collaborate closely with Principal Investigators (PIs) on study development, implementation, and execution. Coordinate protocol development, study start-up, operations, financial management, staffing, and study close-out as needed. Provide administrative leadership in the development, interpretation, and implementation of research-related policies, procedures, and programs. Establish and maintain procedures to promote participant recruitment, satisfaction, adherence, and retention. Ensure CRO-supported studies comply with all regulatory requirements, study protocols, and institutional policies. Institutional Collaboration and Business Development Serve as a key liaison with UF administration, faculty, and external organizations to coordinate business activities, support strategic initiatives, and navigate industry relationships. Collaborate with Office of Research Affairs (ORA) leadership to promote CRO services, enhance visibility, and expand revenue opportunities. Proactively identify new partnerships with industry sponsors, federal agencies, and non-federal organizations to secure funding and grow clinical research programs supported by the CRO. Expected Salary:

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Required Qualifications:

Master’s degree in appropriate areas of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.

Preferred: Master’s degree in clinical research, Public Health, Healthcare Administration, Nursing, or a related field. 3 or more years of progressive experience in clinical research operations within an academic medical center, health system, or contract research organization. Demonstrated experience supervising and leading multidisciplinary clinical research teams, including direct oversight of staff performance, workload distribution, coaching, mentoring, and professional development. Proven ability to build, manage, and retain high-performing teams, including experience with hiring, onboarding, performance evaluations, and corrective action when necessary. Advanced knowledge of FDA regulations, ICH-GCP guidelines, human subjects protections, and institutional review board (IRB) processes. Extensive experience overseeing the full clinical research lifecycle, including study start-up, protocol implementation, participant recruitment and retention, study close-out, and inspection readiness. Strong expertise in research budgeting, financial management, and resource allocation, including oversight of staff effort and study-related costs for industry-sponsored and federally funded studies. Experience developing, implementing, and enforcing standard operating procedures (SOPs), workflows, and quality improvement initiatives. Demonstrated ability to collaborate effectively with Principal Investigators, sponsors, regulatory bodies, and institutional stakeholders.