ASSOCIATE DIRECTOR OF OPERATIONS
Duties: Reporting to the Director of Clinical Research Operations (DCRO) for the Abramson Cancer Center(ACC)- Clinical Research Unit (CRU), the Associate Director of Operations (AD-OP) will be responsible for the frontline direction and planning for day to day clinical research operations. The AP-OP will oversee all operational aspects of the research being performed within the CRU. The AD-OP must have a comprehensive understanding of clinical trial processes and the conduct of clinical research studies. The AD-OP will provide oversight of the daily CRU operations that is aligned with ICH Good Clinical Practice (GCP) to ensure that all staff adhere to the requirements of the University of Pennsylvania and all applicable regulatory bodies.
The AD-OP will serve as the day to day CRU operations lead for the ACC CRU physician lead investigators, clinical research staff, and collaborative health system departments.
* The AD-OP will directly manage and supervise the CRU Central Operations staff including the Biospecimen Manager, the Multi-Site Project Manager, Float staff (Clinical Research Nurses and Research Assistants). This includes responsibility for performance management and overseeing hiring.
* The CRU Research Team managers (Program Managers and Lead Research Nurses) will report indirectly to the AD-OP (with primary reporting to the Physician Leaders of their teams).
* The AD-OP will assess the need for additional staff for the CRU and develop plans for hiring additional staff as needed in conjunction with the CRU Research Team Managers and Physician Leaders, the CRU DCRO, and the CRU Medical Director.
* The AD-OP will serve as the primary operations liaison for internal collaborative departments including the University of Pennsylvania's Infusion/CHPS Suite, Pharmacy/IDS, Laboratory/Biospecimens, Radiology/RECIST Core, and ACC clinical practice leaders.
* In conjunction with the Associate Director for Education and Quality Assurance (AD-EDUC & QA), the AD-OP will develop a program to continually assess protocol compliance and data quality across the CRU Research Teams and prepare reports for the CRU DCOM, CRU Medical Director, and the Lead Physician Investigator for each team.
* Work collaboratively with the Program Managers to identify resource requirements for upcoming protocols, forecast logistical issues impacting operations, and ensure smooth transition of protocols from startup, to study activation, to study close out. This includes study selection and prioritization of work.
* In collaboration with the CRU Associate Directors of Regulatory Affairs (AD-RA), AD-EDUC & QA and the DCRO, the AD-OP will facilitate the flow of new ACC CRU research studies through the study life cycle, by identifying operational obstacles and propose improvements to the process.
* Collaborate with the AD-RA, the AD-EDUC & QA, the DCRO and the CRU Medical Director with unit-wide process improvements. Develop operational process improvements and tools to ensure adherence to standard operating procedures, GCP, and requirements of all applicable regulatory bodies, increase unit efficiency, and reduce errors.
* Participate in research team meetings, Research Team meetings, and ongoing protocol training/compliance meetings.
* Interview candidates, check references and make hiring recommendations to Research Teams as requested.
Qualifications: The minimum of a Bachelor's degree and 7 years to 10 years of experience in health administration or related field, or an equivalent combination of education and experience, required. Master's degree preferred. Training and experience in clinical research or clinical research compliance healthcare required. At least 5 years' experience in a hospital academic medical setting or pharma with principle responsibilities related to clinical research and or research education preferred. Oncology experience and prior leadership experience preferred. Able to confidently interact with all levels of management including senior management, physician leaders and others. Must be detail oriented and organized. Excellent verbal/written communication skills required. Prior experience in developing policy or procedural documentation, and/or SOP is required. Excellent technical writing, review, and analytical abilities; Excellent interpersonal and multi-tasking skills. Ability to work collaboratively on all levels and to gain support of others. Ability to develop interdepartmental relationships and form solid collaborations is critical. 5+ years of Good Clinical Practices (GCP) related experience required; Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired. Strong MS Office skills.
Reference Number: 40-28931
Salary Grade: 030
Employment Type: Exempt
Org: CC-Cancer Center
Job Family: B-Executive/Managerial Administration