University of Florida College of Medicine - Jacksonville · 1 day ago
Manager, Clinical Research
University of Florida College of Medicine - Jacksonville is seeking a Clinical Research Manager to lead the Clinical Research Office. This role involves providing leadership, operational oversight, and mentorship in clinical research, ensuring compliance with regulations, and promoting staff development while managing the administrative and financial aspects of research operations.
Higher Education
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 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
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
Qualification
Required
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
Company
University of Florida College of Medicine - Jacksonville
The University of Florida College of Medicine - Jacksonville is a regional campus of the University of Florida comprised of more than 400 UF faculty physicians, 360 resident and fellow physicians, 50 third- and fourth-year medical students and 34 ACGME-accredited residency and fellowship programs.
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
CDA Foundation
2024-03-18Grant
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