Regulatory Lead - Internal CRO Trial Design & Implementation

United States·Gainesvillelead

OtherImplementation

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Quick Summary

Key Responsibilities

Translate approved protocols into coordinated implementation plans and lead regulatory readiness through activation. Coordinate required approvals, essential documents, study-specific plans,

Technical Tools

OtherImplementation

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:

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, escalate 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.
Standardize internal CRO regulatory and trial implementation workflows, monitor service performance, and lead process improvements that increase consistency, efficiency, and accountability across the program.

What We Offer

~3 min read

✓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, LinkedIn Learning, and more

✓Tuition Assistance through the UF Employee Education Program

✓Public Service Loan Forgiveness (PSLF) Eligible Employer

✓Bachelor's degree in clinical research, regulatory affairs, health sciences, public health, or a related field; advanced degree preferred.

✓Four or more years of progressively responsible experience in clinical research regulatory operations, study start-up, or clinical trial management.

✓Demonstrated experience with protocol development, trial design review, and operational feasibility assessment.

✓Experience supporting FDA-regulated and/or investigator-initiated clinical trials, including IND/IDE and sponsor-investigator responsibilities when applicable.

✓Strong working knowledge of ICH GCP, IRB requirements, applicable FDA regulations, and institutional human research protection processes.

✓Experience coordinating study activation and cross-functional implementation across regulatory, data management, pharmacy, laboratory, finance, contracts, and clinical operations.

✓Experience in a CRO, academic research organization, sponsor operations group, or comparable multi-study clinical research environment.

✓Experience developing SOPs, regulatory templates, quality review processes, and study start-up tools.

✓Strong project management skills with demonstrated ability to manage multiple studies, deadlines, dependencies, and stakeholders.

✓CCRP, CCRC, RAC, PMP, or equivalent clinical research, regulatory, or project management certification preferred.

✓Experience serving as a team lead, supervisor, or work lead and providing training, coaching, work assignment, and deliverable review for research staff or analysts.