Oncology Clinical Research Regulatory Lead

Penn State University; États-Unis; Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

The Penn State College of Medicine in Hershey, PA seeks a Clinical Research Regulatory Coordinator to oversee regulatory management for oncology trials conducted by the Experimental Therapeutics (Extract) Team. You will work with investigators, sponsors, CROs, and regulatory offices to ensure compliance with FDA, ICH-GCP, and institutional policies, across start-up, activation, maintenance, and closeout.

Ideal candidates have oncology regulatory affairs experience, strong organization, and the

Qualifications

• Bachelor's Degree
• 3+ years of relevant experience; oncology regulatory experience preferred

Responsabilités

• Coordinate regulatory start-up and activation activities for oncology trials
• Prepare and submit IRB applications, continuing reviews, amendments, and consent revisions
• Maintain regulatory files and Investigator Site Files (ISFs)
• Monitor regulatory approvals and training/compliance deadlines
• Serve as primary regulatory contact for assigned trials

Connaissances

Regulatory affairs

Oncology experience

IRB submissions

Formation

Bachelor's Degree

Outils

Regulatory databases

IRB submission tools

Description du poste

The Penn State College of Medicine in Hershey, PA seeks a Clinical Research Regulatory Coordinator to oversee regulatory management for oncology trials conducted by the Experimental Therapeutics (Extract) Team. You will work with investigators, sponsors, CROs, and regulatory offices to ensure compliance with FDA, ICH-GCP, and institutional policies, across start-up, activation, maintenance, and closeout.

Ideal candidates have oncology regulatory affairs experience, strong organization, and the