Regulatory Lead: Internal CRO Trial Design & Activation

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

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