Oncology Clinical Research Regulatory Lead

The Pennsylvania State University; Hershey (PA); Vor Ort; USD 54.000 - 86.000; Vollzeit

Benefits dieser Stelle

75% tuition discount

Zusammenfassung

The Pennsylvania State University is seeking a Clinical Research Regulatory Coordinator in Hershey, PA to manage regulatory activities for oncology trials conducted by the Experimental Therapeutics team. You will ensure compliance with FDA regulations, ICH-GCP guidelines, and institutional policies while coordinating start-up, maintenance, and closeout activities.

The role requires a Bachelor's degree with 3+ years of regulatory experience in clinical research, familiarity with IND studies, and

Qualifikationen

• Bachelor's Degree and 3+ years of regulatory experience in clinical research.
• Experience with IND studies and ICH-GCP guidelines.
• Familiarity with FDA regulations and IRB submissions.
• Ability to manage multiple trials and deadlines.

Aufgaben

• Coordinate regulatory start-up and activation for oncology trials across sponsors and investigators.
• Prepare and submit IRB applications, continuing reviews, amendments, and consent revisions.
• Maintain ISFs and regulatory files; monitor approvals and compliance deadlines.
• Serve as regulatory lead for assigned trials; liaise with investigators, sponsors, CROs, and regulatory offices.
• Support study closeout, sponsor monitoring, and regulatory inspections.

Kenntnisse

Regulatory affairs

Oncology experience

IRB submissions

Regulatory documentation

Ausbildung

Bachelor's Degree

Tools

eRegulatory systems

Jobbeschreibung

The Pennsylvania State University is seeking a Clinical Research Regulatory Coordinator in Hershey, PA to manage regulatory activities for oncology trials conducted by the Experimental Therapeutics team. You will ensure compliance with FDA regulations, ICH-GCP guidelines, and institutional policies while coordinating start-up, maintenance, and closeout activities.

The role requires a Bachelor's degree with 3+ years of regulatory experience in clinical research, familiarity with IND studies, and