[Hiring] Research Project Manager Regulatory @Penn State University

Role Description

The Beat Childhood Cancer (BCC) Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Regulatory Project Manager. This position supports clinical trial research across 55+ hospital sites on 10+ clinical trials with a focus on:

• Regulatory compliance
• Study-start up activities
• Regulatory document collection and maintenance

Key responsibilities include:

• Developing and administering the regulatory compliance program for BCC.
• Overseeing Study Start-up, Trial Life-cycle, and Study Closeout regulatory responsibilities.
• Maintaining Florence eBinder TMF/ISF management.
• Interpreting federal and state regulations concerning BCC’s compliance program.
• Maintaining compliance with Good Clinical Practice (GCP) guidelines.
• Guiding and training others in regulatory compliance activities.
• Managing internal and external audits.
• Developing relationships with BCC and University staff, research collaborators, and regulators.
• Implementing new guidelines and procedures to streamline operations.
• Adapting to changing circumstances in a fast-paced environment.
• Exhibiting excellent organizational skills and communication abilities.

Qualifications

• Master's Degree
• 6+ years of relevant experience; or an equivalent combination of education and experience accepted.
• Strong background in working with central and Institutional Review Boards (cIRB/IRB), GCP, and FDA IND requirements.
• Experience with multiple Principal Investigators and Phase I/II clinical trial projects.
• Strong verbal and written communication skills.
• Ability to multi-task while fostering collaboration and teamwork.

Requirements

• Flexibility to adapt to changing circumstances.
• Ability to work in a fast-paced environment.
• Some required travel (up to quarterly; likely bi-annual) per year.

Benefits

• Salary range: $81,312.00 - $122,016.00.
• Comprehensive medical, dental, and vision coverage.
• Robust retirement plans.
• Substantial paid time off including holidays, vacation, and sick time.
• Generous 75% tuition discount for employees and eligible family members.