Clinical Research Regulatory Lead — Flexible Hours

Upenn; Philadelphia (Philadelphia County); On-site; USD 76,000 - 78,000; Full time

Benefits offered by this job

Health benefits

Tuition benefits

Retirement plans

Flexible work hours

Wellness programs

Job summary

The University of Pennsylvania's Perelman School of Medicine seeks a Clinical Research Regulatory Specialist C in Philadelphia to lead regulatory operations for NIH and industry-sponsored trials. You will manage IRB submissions, liaise with sponsors, CROs, and FDA, and guide junior staff in regulatory practices while ensuring compliance across study phases.

This full-time role emphasizes regulatory excellence within a world-renowned medical research environment and offers comprehensive Penn

Qualifications

• Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.

Responsibilities

• Lead regulatory operations for NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division.
• Independently manage submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies.
• Oversee regulatory documentation, resolve complex compliance issues, and direct study initiation, monitoring, audit, and close-out visits.

Skills

Regulatory management

IRB submissions

Regulatory compliance

Sponsor/CRO liaison

FDA regulatory interactions

Education

Bachelor's degree

Job description

The University of Pennsylvania's Perelman School of Medicine seeks a Clinical Research Regulatory Specialist C in Philadelphia to lead regulatory operations for NIH and industry-sponsored trials. You will manage IRB submissions, liaise with sponsors, CROs, and FDA, and guide junior staff in regulatory practices while ensuring compliance across study phases.

This full-time role emphasizes regulatory excellence within a world-renowned medical research environment and offers comprehensive Penn