Senior Clinical Research Regulatory Lead

Opportunity for Health; Pennsylvania, United States, Northern America, Americas; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, Life, and Flexible Spending

Tuition benefits

Long-Term Care Insurance

Wellness and Work-life Resources

Job summary

The University of Pennsylvania's Perelman School of Medicine seeks a regulatory research professional to coordinate unit clinical research, manage regulatory submissions through the IRB and review committees, and maintain regulatory documentation andISF files for sponsors and agencies.

You will lead initiation, monitoring, audits, and close-out visits; supervise junior staff, develop study tools, and assist with procurement of trial supplies.

Qualifications

• Experience coordinating regulatory aspects of clinical trials (Phase I–IV).
• Ability to prepare regulatory submissions and maintain ISF/documents.
• Strong knowledge of IRB/ethics review processes and sponsor interactions.

Responsibilities

• Coordinate unit clinical research including Phase I–IV trials.
• Prepare and process regulatory documentation through the IRB and review committees.
• Maintain regulatory documentation/ISF files for sponsors and governmental agencies.
• Lead initiation, monitoring, audit and close-out visits.

Skills

Regulatory documentation

IRB submissions

Regulatory compliance

Clinical research coordination

Team leadership

Mentoring/Training

Vendor coordination

Job description

The University of Pennsylvania's Perelman School of Medicine seeks a regulatory research professional to coordinate unit clinical research, manage regulatory submissions through the IRB and review committees, and maintain regulatory documentation andISF files for sponsors and agencies.

You will lead initiation, monitoring, audits, and close-out visits; supervise junior staff, develop study tools, and assist with procurement of trial supplies.