Oncology Clinical Research Regulatory Specialist

The Pennsylvania State University; Hershey (PA); On-site; USD 54,000 - 86,000; Full time

Benefits offered by this job

Tuition discount 75%

Robust retirement plans

Paid time off

Job summary

The Pennsylvania State University in Hershey, PA is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for Oncology trials conducted by the Extract Team at Penn State College of Medicine. This role supports start-up, activation, ongoing maintenance, and closeout across an assigned portfolio.

You will ensure FDA/ICH-GCP compliance, prepare IRB submissions, maintain regulatory files, and collaborate with investigators, coordinators, sponsors, CROs, and regulatory

Qualifications

• Bachelor's Degree and 3+ years of regulatory experience.
• Experience with FDA regulations, IND studies, and ICH-GCP.
• Proficiency with IRB submissions and regulatory documents.

Responsibilities

• Coordinate regulatory start-up and activation for oncology trials.
• Prepare IRB applications, amendments, and continuing reviews.
• Maintain Investigator Site Files and regulatory documents.
• Ensure study compliance and audit readiness throughout closeout.

Skills

Regulatory management

IRB submissions

Oncology trials

Regulatory compliance

Communication

Education

Bachelor's Degree

3+ years of relevant experience

Tools

Electronic regulatory document management systems

Job description

The Pennsylvania State University in Hershey, PA is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for Oncology trials conducted by the Extract Team at Penn State College of Medicine. This role supports start-up, activation, ongoing maintenance, and closeout across an assigned portfolio.

You will ensure FDA/ICH-GCP compliance, prepare IRB submissions, maintain regulatory files, and collaborate with investigators, coordinators, sponsors, CROs, and regulatory