Clinical Trial Start-Up & Regulatory Specialist

upenn; Upper Paxton Township (PA); On-site; USD 85,000 - 105,000; Full time

Job summary

The Penn Neurogenetics Therapy Center (PNTC) is seeking a Clinical Research Regulatory Specialist B to support trial startup and ongoing regulatory activities across its portfolio, ensuring compliance with institutional and federal regulations and ICH-GCP guidelines.

You will coordinate regulatory submissions, manage essential trial documentation, and collaborate with investigators, sponsors, CROs, and internal offices to enable timely trial activations and continuous regulatory support

Responsibilities

• Coordinate clinical trial startup from feasibility through site activation, tracking regulatory submissions and essential study documentation.
• Prepare and process regulatory submissions to IRB and ancillary committees; collect and submit essential regulatory documentation to sponsors, CROs, and applicable entities.
• Provide ongoing regulatory support for active trials, including protocol amendments, continuing reviews, reportable events, and updates to study documents.
• Maintain complete, inspection-ready regulatory documentation and investigator site files throughout the study lifecycle, in line with regulatory requirements.
• Resolve regulatory queries and support study oversight activities, including site initiation, monitoring, audit, inspection, and close-out.
• Participate in study team meetings, protocol/regulatory training, and contribute to process improvements in regulatory and startup workflows.

Job description

The Penn Neurogenetics Therapy Center (PNTC) is seeking a Clinical Research Regulatory Specialist B to support trial startup and ongoing regulatory activities across its portfolio, ensuring compliance with institutional and federal regulations and ICH-GCP guidelines.

You will coordinate regulatory submissions, manage essential trial documentation, and collaborate with investigators, sponsors, CROs, and internal offices to enable timely trial activations and continuous regulatory support