Reporting to the Director of Clinical Research Operations for the Abramson Cancer Center(ACC)- Clinical Research Unit (CRU), the Associate Director for Regulatory Affairs (AD-RA) will oversee the ACC CRU portfolio of oncology trials (approximately 400+ trials across ACC clinical locations). The AD-RA is responsible for providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of CRU Regulatory Office, anticipating and planning for changes in the regulations governing clinical cancer research, planning for the regulatory aspects of growth of CRU research activity within the Penn Medicine network, and liaising with regulatory groups in the Cancer Center, University, and federal government. The candidate must have a thorough knowledge of ICH-GCP regulations and a comprehensive understanding of clinical trial processes and the conduct of clinical research studies.
The AD-RA will directly manage and supervise the Manager of Regulatory Affairs. In this capacity, the AD-RA will have oversight of all regulatory staff, including monitoring workload intensity and tracking deadlines to ensure timely and appropriate regulatory reporting and compliance for ACC CRU trials. The AD-RA will establish and maintain Standard Operating Procedures for the Regulatory Office to ensure adherence to regulatory requirements of the University of Pennsylvania and all applicable regulatory bodies. In conjunction with the Manager of Regulatory Affairs, the AD-RA will evaluate regulatory staff performance and identify areas for improvement. In conjunction with the Associate Director, Education and Quality Assurance, the AD-RA will oversee ongoing training for all ACC CRU staff pertaining to regulatory affairs and compliance requirements; In collaboration with the CRU Associate Director of Operations (AD-OP), Associate Director for Education and Quality Assurance (AD-EDUC & QA), Director of Clinical Research Operations (DCRO), and Medical Director, the AD-RA will ensure that the Standard Operating Procedures of the CRU are aligned with FDA, ICH, NIH/NCI and industry standards.
The AD-RA will serve as the primary resource for the ACC CRU Physician-Investigators and clinical research staff on regulatory affairs matters. In collaboration with the AD-EDUC & QA and the CRU Medical Director, the AD-RA will develop a training program for investigators to enhance understand of and compliance with applicable regulations.
The AD-RA will also serve as the primary liaison for internal regulatory groups including the University of Pennsylvania’s Institutional Review Board (IRB), ACC Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), the Data Safety & Monitoring Committee (DSMC), the Department of Operations, Compliance & Monitoring (DOCM), and the Office of Clinical Research (OCR); as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and the NCI Cooperative/Clinical Network Groups 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, NCI Cooperative/Clinical Network Groups and other University Departments. He/she will assist with the development of investigator-initiated research protocols and development/maintenance of study specific case report forms and source document tools and will oversee the development and submission of FDA IND applications, IND exemptions, and annual reports. He/she will provide direct regulatory and compliance guidance of multi-site investigator initiated trials including: directing the 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 ACC CRU.
The AD-RA will work collaboratively with the Program Managers to identify resource requirements for upcoming protocols, forecast logistical issues impacting regulatory compliance, and ensure smooth transition of protocols from regulatory start up to study activation. In collaboration with the AD-OP, AD-EDUC & QA and the DCRO, the AD-RA will facilitate and track the flow of new ACC CRU research studies through the start-up process, by identifying regulatory obstacles to activation, and propose improvements to the process 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 conjunction with the AD- EDUC & QA, the AD-RA will facilitate ongoing improvement of clinical trial compliance and quality assurance through communication of audit results and compliance guidelines.
The AD-RA will have oversight of regulatory submissions to the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will oversee the organization and maintenance of all regulatory affairs documentation/files. He/she will provide leadership to resolve regulatory and data queries through close collaboration with auditors, involved business units, investigators, research teams, and research partners. He/she will participate in initiation, monitoring, audit and close-out study visits. He/she will participate as needed in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings.
A minimum of a Bachelor’s degree and 7-10 years of experience conducting/overseeing clinical research including research compliance, or an equivalent combination of education and experience, are required. Master’s Degree in a related field is preferred. CIP and/or RAC credentials highly desired. At least two to three years’ experience in a hospital academic medical setting or pharma with principle responsibilities related to regulatory affairs, research compliance, or clinical research is preferred. Oncology experience preferred. Thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including FDA regulations, International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines for the conduct of clinical trials, and IRB/Human Research Protection Regulations. Must have excellent problem solving abilities, critical thinking skills, excellent communication and writing skills, strong organizational and time management skills, and strong leadership abilities. Ability to interpret regulations and laws, and disseminate information is desired. Strong MS Office skills. Must be flexible, organized, and be able to multi-task. Must be able to travel between clinical locations as needed.
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