Oncology Clinical Trials Regulatory Coordinator

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

Benefits offered by this job

75% tuition discount

Retirement plans

Paid time off

Job summary

The Penn State College of Medicine in Hershey, PA is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for oncology trials conducted by the Experimental Therapeutics (Extract) Team. This role supports study start-up, activation, ongoing maintenance, and closeout.

The ideal candidate has oncology regulatory experience, strong organization, and the ability to manage multiple studies and deadlines independently.

Qualifications

• Bachelor's Degree with relevant experience or equivalent combination.
• Experience with regulatory submissions for oncology trials preferred.
• Knowledge of FDA regulations, INDs, and ICH-GCP guidelines.

Responsibilities

• Regulatory study start-up and maintenance for oncology trials.
• Prepare and submit IRB applications and amendments.
• Maintain regulatory files and ISFs with timely submissions.
• Coordinate with investigators, sponsors, CROs and regulatory offices.

Skills

Regulatory management

Oncology trials

IRB submissions

FDA regulations

ICH-GCP guidelines

Independent study management

Education

Bachelor's Degree 3+ years experience

Bachelor's Degree 1+ years experience

Tools

Electronic regulatory documents systems

Job description

The Penn State College of Medicine in Hershey, PA is seeking a Clinical Research Regulatory Coordinator to manage regulatory activities for oncology trials conducted by the Experimental Therapeutics (Extract) Team. This role supports study start-up, activation, ongoing maintenance, and closeout.

The ideal candidate has oncology regulatory experience, strong organization, and the ability to manage multiple studies and deadlines independently.