Regulatory Lead - Internal CRO Trial Design & Implementation

University of Florida; Gainesville (FL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

State health plans

Life & disability insurance

Generous retirement options

Paid time off & holidays

Professional development

Job summary

The University of Florida on its Main Campus in Gainesville seeks a Regulatory Lead for its Regulatory Hub within the Internal CRO Trial Design & Implementation program. You will provide regulatory and operational leadership for CRH-supported clinical trials from concept to activation, partnering with investigators and cross-functional teams to translate concepts into compliant protocols.

You will supervise clinical research analysts, manage submissions, ensure ICH-GCP compliance, and drive

Qualifications

• Master's degree in an appropriate area with 2+ years of relevant experience, or Bachelor's degree with 4+ years of relevant experience.
• Regulatory lead for internal CRO projects with cross-functional collaboration to ensure compliant study execution.

Responsibilities

• Lead regulatory and operational consultation during concept and protocol development for investigator-initiated and CRH-supported trials.
• Review study design, objectives, endpoints, eligibility criteria, data collection, and operational feasibility.
• Assess regulatory pathways and submission requirements, including IRB strategy and IND/IDE considerations when applicable.
• Coordinate approvals, essential documents, and cross-functional start-up activities with data management, pharmacy, and clinical operations.
• Maintain submission timelines and regulatory trackers; manage regulatory deliverables as applicable.
• Provide supervision to CRAs and standardize internal CRO regulatory workflows; drive process improvements.

Skills

Regulatory leadership

Trial design

IRB strategy

ICH GCP compliance

Study start-up

Project management

Education

Master's degree in clinical research or related field

Bachelor's degree in related field

Job description

Regulatory Lead - Internal CRO Trial Design & Implementation

Job No: 541647

Work Type: Full Time

Location: Main Campus (Gainesville, FL)

Categories: Grant or Research Administration, Health Care Administration/Support

Department: 29011700 - MD-OFFICE OF RESEARCH

Job Description

Classification Title:

Clinical Research Analyst IV

Classification Minimum Requirements:

Master's degree in an appropriate area and two years of relevant experience; or a Bachelor's degree in an appropriate area and four years of relevant experience; or an equivalent combination of education and experience.

Job Description:

The Regulatory Lead for Internal CRO Trial Design & Implementation provides regulatory and operational leadership for Clinical Research Hub (CRH)-supported clinical trials from concept development through study activation and implementation. The Lead functions as a regulatory subject matter expert within CRH's internal CRO model, partnering with investigators and cross-functional research teams to translate scientific concepts into feasible, compliant protocols and execution plans. This crucial role coordinates with investigators, biostatistics, data management, pharmacy, finance, contracts, compliance, and other institutional partners to support efficient, compliant study execution.

Essential Functions:

Trial Design and Regulatory Strategy:

• Lead regulatory and operational consultation during concept and protocol development for investigator-initiated and other CRH-supported clinical trials.
• Review study design, objectives, endpoints, eligibility criteria, intervention plans, safety monitoring, schedules of assessments, data collection, and operational feasibility.
• Assess regulatory pathways and submission requirements, including IRB strategy, sponsor-investigator responsibilities, and IND/IDE considerations when applicable.
• Identify design or compliance gaps early and develop practical mitigation plans with investigators and CRH partners.

Study Start-Up and Implementation:

• Translate approved protocols into coordinated implementation plans and lead regulatory readiness through activation.
• Coordinate required approvals, essential documents, study-specific plans, delegation and training requirements, and cross-functional start-up activities with data management, pharmacy, laboratory, finance, contracts, and clinical operations.
• Confirm that regulatory and operational requirements are complete before study launch and support structured handoff into active study conduct.

Internal CRO Regulatory Operations and Project Management:

• Serve as the regulatory lead for an assigned portfolio of internal CRO projects.
• Maintain submission and activation timelines, regulatory trackers, essential documentation, and status reporting.
• Coordinate initial submissions, amendments, continuing review, reportable events, and other regulatory deliverables as applicable.
• Manage dependencies, Escalate barriers, and facilitate decisions across investigators and institutional stakeholders to keep studies moving toward planned milestones.

Quality, Compliance, Training, and Inspection Readiness:

• Perform quality review of protocols, submissions, regulatory files, and implementation materials for consistency with applicable regulations, ICH GCP, IRB requirements, and institutional policy.
• Develop and maintain SOPs, templates, checklists, and training resources for the internal CRO.
• Provide regulatory education and consultation to investigators and research teams, support corrective action and process improvement, and promote ongoing inspection readiness.

Staff Supervision and Program Improvement:

• Provide direct supervision to the assigned Clinical Research Analysts (CRAs), including work assignment, prioritization, coaching, quality review, performance feedback, and professional development support.
• Standardize internal CRO regulatory and trial implementation workflows, monitor service performance, and lead process improvements that increase consistency, efficiency, and accountability across the program.

We Offer Exceptional Benefits:

• Low-cost State Health Plans: Medical, Dental, and Vision Insurance
• Life and Disability Insurance
• Generous Retirement Options to secure your future
• Comprehensive Paid Time Off Packages with 10+ paid holidays, paid family, sick and vacation leave
• Exceptional Personal and Professional Development Opportunities: Access to UF Training & Organizational Development programs, leadership development,