Remote Regulatory Project Manager – Clinical Trials

Penn State Lady Lions; Hershey (PA); Remote; USD 81,000 - 122,000; Full time

Job summary

Penn State Lady Lions is seeking a full-time Clinical Trial Regulatory Project Manager for the Beat Childhood Cancer Research Consortium in Hershey, PA. The role ensures regulatory compliance across 55+ hospital sites and 10+ trials, focusing on start-up activities, documentation, and internal controls.

This is a remote position with travel requirements. Ideal candidates have strong cIRB/IRB, GCP, and FDA IND experience, plus a Master’s degree and 6+ years in clinical research regulation.

Qualifications

• Master's Degree and 6+ years of relevant experience, or an equivalent combination of education and experience.
• Experience with cIRB/IRB, GCP, and FDA IND requirements.
• Remote position with travel up to quarterly (likely bi-annual) per year.

Responsibilities

• Develop and administer regulatory compliance program for the Beat Childhood Cancer Research Consortium (BCC). Provide guidance and oversight for regulatory documentation maintenance and management of regulatory processes.
• Oversee Study Start-up, Trial Life-cycle, and Study Closeout at Sponsor level regulatory responsibilities and maintain Florence eBinder TMF/ISF management.
• Develop and administer compliance programs with continuous analysis and implement action plans for the consortium and 54+ sites.
• Interpret and stay up to date on FDA, GCP, ICH, and other regulatory changes affecting BCC's programs.
• Maintain compliance with GCP guidelines throughout the trial life cycle.
• Serve as liaison between senior BCC management and sites on regulatory compliance and inquiries.
• Direct, manage, and oversee internal audits, external audits, pre-inspections, and responses to non-compliance.

Skills

Regulatory compliance

Study start-up

Clinical trials

Team collaboration

IRB/cIRB

Education

Master's Degree

Tools

Florence eBinder

Job description

Penn State Lady Lions is seeking a full-time Clinical Trial Regulatory Project Manager for the Beat Childhood Cancer Research Consortium in Hershey, PA. The role ensures regulatory compliance across 55+ hospital sites and 10+ trials, focusing on start-up activities, documentation, and internal controls.

This is a remote position with travel requirements. Ideal candidates have strong cIRB/IRB, GCP, and FDA IND experience, plus a Master’s degree and 6+ years in clinical research regulation.