Manager, Clinical Research

University of Florida•Jacksonville, FL

1d•Onsite

About The Position

The Clinical Research Manager provides leadership and clinical trial competence 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 player in developing guidelines and criteria to enhance the selection of clinical research studies for the campus. The core function of this role is to educate and train new investigators in the life cycle of clinical trials and best practices for interacting with sponsors and other stakeholders (i.e., IRB, Privacy Office). Responsibilities include overseeing study planning and execution, preparing and reviewing research protocols, and ensuring compliance with FDA regulations and institutional policies. The Clinical Research Manager serves as a key resource for investigators, sponsors, and research staff, providing guidance on feasibility, clinical trial implementation, regulatory requirements, and research operations. 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. The Clinical Research Manager will support the expansion of clinical trial accessibility to all communities and facilities of the UF Health enterprise, working strategically with ORA leadership. This position will provide support to enhance the CRO capabilities for increased decentralized trials to promote greater participant convenience and retention. 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.

Requirements

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

Nice To Haves

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 trial 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.

Responsibilities

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.
Deliver hands-on training to new investigators in clinical trial implementation and operations, education, and insights to the entire life cycle of a sponsored clinical trial.
The training will involve interactions with several internal and external stakeholders, including but not limited to IRB, Privacy, sponsored research, IT, and relevant ancillary services.
The training and mentorship will provide an understanding of the responsibilities and account investigator of clinical research studies, along with the professional benefits for career growth.
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.
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.
Enhance CRO capabilities for increasing the volume of decentralized trials, improving utilization of telehealth, digital health, and other technology-based tools.