Position Type : Full Time
The Assistant Director for Regulatory Affairs will oversee the portfolio of newly proposed and ongoing studies in the Departments of Orthopaedic Surgery and Anesthesiology & Critical Care (approximately 200 active across four clinical locations: at Weightman Hall, the Hospital of the University of Pennsylvania, Presbyterian Hospital, and Pennsylvania Hospital) run under the shared Clinical Research Unit of the two departments as related to providing support and strategic planning for clinical regulatory operations and establishing, maintaining, and enhancing adherence to institutional, state, and federal regulations and good clinical practice guidelines.
He/she will serve as the primary resource for the departments’ Physician-Investigators and clinical staff on regulatory affairs and compliance issues. He/she will serve as the primary liaison with pharmaceutical companies, contract research organizations, the FDA, the NCI Cooperative Groups, other University Departments, and other entities as required, in the conduct of clinical trials. He/she will oversee preparations for and serve as a primary liaison related to regulatory audits by the FDA, NIH, DOD, other funders and other University Departments. He/she will oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications, IND exemptions, annual reports, and development/maintenance of study specific case report forms and source document tools. He/she will provide direct regulatory/compliance guidance and oversight of multi-site investigator initiated trials including: development of multisite manuals of procedure, obtaining regulatory approvals, conducting site initiation visits, and ensuring necessary and sufficient sponsor oversight. He/she will facilitate collaborations in the conduct of clinical trials between other departments, centers, researchers and the departments.
He/she will work collaboratively with the nursing staff and departmental leadership to appropriately resource incoming protocols, address logistical issues impacting regulatory compliance, and ensure smooth transition of protocol from regulatory start up to study activation. He/she will facilitate and track the flow of new research studies through the start-up process, identify obstacles to activation, and propose improvements to the process. He/she will track, analyze and report to senior leadership unit-wide trial characteristics, accrual information and audit/monitoring findings; such reports will include an assessment of trial information, areas of potential risk or roadblocks to success, and potential corrective actions. In this role, he/she will facilitate ongoing improvement of clinical trial compliance and quality assurance through communication of audit results and compliance guidelines.
He/she will prepare and process regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events as needed. He/she will prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NIH and other funders and the FDA as needed. He/she will oversee the organization and maintenance of all regulatory affairs documentation/files as required. He/she will provide leadership to resolve regulatory and data queries as needed through close collaboration with auditors, involved business units, investigators, study teams and research partners. He/she will participate in initiation, monitoring, audit and close-out study visits. He/she will participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings.
Future responsibilities will include supervision, management, leadership and training to the clinical research staff; directly supervising Regulatory Coordinators and Administrative Support Staff as expansion may dictate. In this capacity, he/she would delegate and monitor assignments and workload for the Regulatory Office team to ensure timely and appropriate regulatory upkeep and compliance for all ongoing trials. He/she would manage ongoing regulatory staff performance, identify areas for improvement, and provide ongoing training to all faculty, staff and trainees in regulatory affairs and compliance issues. He/she will oversee compliance and quality assurance activities within the two departments and assist in the development and maintenance of Internal Operating Procedures aligned with FDA, ICH, NIH and industry standards.