Clinical Research Regulatory Lead - Flexible Hours

Opportunity for Health; Philadelphia (Philadelphia County); On-site; USD 76,000 - 78,000; Full time

Benefits offered by this job

Health, Life, and Flexible Spending

Tuition benefits

Retirement plans

Flexible work hours

Job summary

The University of Pennsylvania's Perelman School of Medicine in Philadelphia, PA is seeking a Clinical Research Regulatory Specialist C to manage regulatory operations for NIH and industry-sponsored trials in the Neuroradiology Clinical Research Division.

The role requires a Bachelor's degree and 5–7 years of relevant experience, with responsibilities including IRB submissions, regulatory documentation, study initiation, monitoring, and training junior staff in regulatory practices.

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 clinical research and oversee submissions to IRBs, committees, sponsors, CROs, FDA.
• Develop regulatory tools and processes and provide expert regulatory guidance and compliance.
• Train/mentor junior staff in regulatory practices and study oversight.
• Serve as a liaison for regulatory oversight with investigational teams, nursing units, sponsors, and CROs.

Skills

Regulatory management

Clinical trial oversight

IRB submissions

Regulatory documentation

Training & mentoring

Education

Bachelor's degree

Job description

The University of Pennsylvania's Perelman School of Medicine in Philadelphia, PA is seeking a Clinical Research Regulatory Specialist C to manage regulatory operations for NIH and industry-sponsored trials in the Neuroradiology Clinical Research Division.

The role requires a Bachelor's degree and 5–7 years of relevant experience, with responsibilities including IRB submissions, regulatory documentation, study initiation, monitoring, and training junior staff in regulatory practices.