Clinical Research Regulatory Lead

Trustees of University of Pennsylvania; Upper Paxton Township (PA); On-site; USD 76,000 - 78,000; Full time

Job summary

The University of Pennsylvania's Perelman School of Medicine in Philadelphia seeks a Clinical Research Regulatory Specialist C to oversee regulatory operations for NIH and industry-sponsored trials. You will manage submissions to IRBs, sponsors, CROs, FDA, and regulators, ensuring compliance and study integrity.

You will develop regulatory tools and provide expert guidance, mentoring junior staff in regulatory practices and study oversight while coordinating with investigators, nursing units,

Qualifications

• Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.
• Experience leading regulatory operations for clinical trials.
• Knowledge of NIH/industry-sponsored regulatory requirements.

Responsibilities

• This position will be a resource for regulatory management and oversight with NIH and Industry-sponsored clinical trials.
• Lead regulatory operations for clinical research and submissions to IRBs, sponsors, CROs, FDA, and regulators.
• Develop regulatory tools, guidance, and mentor junior staff in regulatory practices.

Skills

Regulatory compliance

Clinical research

IRB submissions

Regulatory oversight

Education

Bachelor's degree

Job description

The University of Pennsylvania's Perelman School of Medicine in Philadelphia seeks a Clinical Research Regulatory Specialist C to oversee regulatory operations for NIH and industry-sponsored trials. You will manage submissions to IRBs, sponsors, CROs, FDA, and regulators, ensuring compliance and study integrity.

You will develop regulatory tools and provide expert guidance, mentoring junior staff in regulatory practices and study oversight while coordinating with investigators, nursing units,