Regulatory Lead - Internal CRO Trial Design & Implementation

Job no: 541647
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration, Health Care Administration/Support
Department:  - MD-OFFICE OF RESEARCH

Clinical Research Analyst IV

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.

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.

• 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.

• 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.

• 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, elevate barriers, and facilitate decisions across investigators and institutional stakeholders to keep studies moving toward planned milestones.

• 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.

• Provide direct supervision to the assigned Clinical Research Analysts (CRAs), including work assignment, prioritization, coaching, quality review, performance feedback, and professional development support.
• Standardiz…