Remote Regulatory Project Manager - Clinical Trials

Penn State University; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Penn State University’s Beat Childhood Cancer Research Consortium, based at the Penn State College of Medicine in Hershey, seeks a full-time Clinical Trial Regulatory Project Manager to lead regulatory compliance, study start-up activities, and TMF/ISF management across 55+ hospital sites.

The role emphasizes federal and state regulation, audits, and ensuring GCP compliance throughout trial lifecycles, with remote work and occasional travel.

Qualifications

• Experience with cIRB/IRB, GCP and FDA IND requirements.
• Strong cross-functional collaboration with multiple principal investigators.
• Remote position with travel up to quarterly per year.

Responsibilities

• Develop and administer regulatory compliance program for BCC; oversee regulatory documentation.
• Oversee study start-up, trial life-cycle and study closeout at sponsor level; manage Florence eBinder/ISF TMF.
• Design and implement compliance programs; ensure regulatory processes meet changes in FDA, GCP, and ICH.

Skills

Regulatory compliance

GCP

FDA IND

IRB experience

Audit management

Stakeholder communication

Education

Master's Degree

Tools

Florence eBinder

Job description

Penn State University’s Beat Childhood Cancer Research Consortium, based at the Penn State College of Medicine in Hershey, seeks a full-time Clinical Trial Regulatory Project Manager to lead regulatory compliance, study start-up activities, and TMF/ISF management across 55+ hospital sites.

The role emphasizes federal and state regulation, audits, and ensuring GCP compliance throughout trial lifecycles, with remote work and occasional travel.