Clinical Research Manager – UF Department of Emergency Medicine

University of Florida•Gainesville, FL

1d•Onsite

About The Position

The University of Florida, Department of Emergency Medicine is seeking a Clinical Research Manager to join our team. In this role, you will provide leadership and oversight of our clinical research mission, encompassing regulatory compliance, study operations, and administrative management to ensure all activities are conducted in accordance with the Federal regulations and University and Department policies. Collaborating closely with the Vice Chair of Research, Department Administration, and Principal Investigators, you will support the full lifecycle of clinical studies, from proposal development through study initiation, execution, and closeout. This role supervises an excellence-driven team of research admin and clinical staff to drive operational efficiency and program growth across an expansive portfolio of funded grants and clinical trials. The UF Department of Emergency Medicine proudly maintains an affiliation with UF Health Shands Hospital, a distinguished 1,162-bed teaching facility renowned for its Level 1 trauma center and cutting-edge burn center. As the primary referral center for North Central Florida, our institution stands as a beacon of excellence in healthcare. This affiliation underscores our commitment to top-tier medical care and innovation.

Requirements

Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.
Experience leading and supervising multidisciplinary teams in a clinical research or healthcare environment.
Demonstrated experience growing a clinical research program, including expansion of study portfolio and research funding.
Strong financial and budgeting skills, including research budgeting, resource allocation, and financial tracking.
Familiarity with database construction, data collection, and data entry.
Experience supporting manuscript preparation and scientific publication.
Strong organizational and project management skills, with the ability to plan, prioritize, and coordinate work assignments.
Excellent verbal and written communication skills.
Proficiency with standard computer applications and research-related systems.
Ability to interpret and apply applicable regulations, policies, and procedures related to clinical research.
Ability to independently manage administrative and research support tasks.
Experience collecting and organizing data for scientific presentation and reporting.

Responsibilities

Direct research compliance and regulatory oversight in collaboration with Principal Investigators, research coordinators, associates, support staff, the department, the Institutional Review Board, and Research Administration and Compliance.
Develop training materials, maintain the department's standard operating procedures for research, and ensure all study personnel meet mandatory Federal and IRB training requirements.
Oversee IRB and WIRB submissions, continuing reviews, and serious adverse event reporting, and attend IRB meetings for department protocols.
Ensure proper organization of regulatory binders and study files, and coordinate internal audits as needed.
Plan and direct research operations, including staffing and resource projections, monthly reconciliation, and enrollment tracking across the study portfolio.
Collaborate with departmental administrative staff to communicate anticipated PI effort changes tied to new study proposals, award initiations, and award closeouts.
Supervise research coordinators, clinical research nurses, OPS Research Associates, an OPS Research Data Analyst, and the Medical Student Research Program (MSRP), including hiring, scheduling, and performance evaluation.
Supervise clinical coordinators and nurses in the day-to-day conduct of research, including informed consent, subject eligibility screening, data collection, and study documentation.
Assist PIs in developing feasible study proposals, including specific aims, feasibility assessments, and collaboration with a biostatistician on sample size and power analysis.
Support PIs with budget preparation, staff effort estimates, and sponsor contract compliance.
Facilitate scientific and compliance reporting, including study registration at ClinicalTrials.gov, and oversee accurate, timely project closeout and secure retention of study records.
Support PIs with data analysis, abstract preparation, and manuscript development for conference and publication submissions.