DIRECTOR OF CLINICAL RESEARCH OPERATIONS
Duties: The Director of Clinical Research Operations implements and oversees operational aspects of research within the Abramson Cancer Center's Clinical Research Unit (CRU). The incumbent provides regulatory guidance and clinical research support to a diverse group of investigators ensuring compliance with investigator initiated as well as sponsored projects (federal and non federal). This position serves as a Senior Administrative liaison between investigators, clinical research projects and clinical research support staff housed within the disease team units
The Director supports the ACC's Clinical Research Unit enterprise by:
* Providing advice, counsel and strategic direction to senior research administration and Institutional officials
* Supporting and encouraging new and ongoing clinical research programs
* Raising the level of awareness of the strategic and economic importance of clinical research to internal and external customers
* Interfacing with multiple PENN Medicine Physician Leaders and Administrators at multiple sites to assist with the expansion of the breadth of clinical research across Penn Medicine owned and affiliated entities
* Enhancing the brand of a world-class clinical research program in an NCI -designated comprehensive research center
Clinical Research Management
* Developing and maintain tools, processes, training programs, and standard operating procedures (SOPs) designed to support the conduct of clinical research within the CRU
* Working closely with research administration and physician leadership to strengthen the culture of clinical research.
* Supporting a varied portfolio of clinical research efforts throughout the institution
* Overseeing the provision of services designed to assist the research community with comprehensive and strategic recruitment plans to maximize recruitment efforts for clinical research projects
* Working with established ACC, PSOM and University departments to ensure adherence to protocol and sponsor regulations and safety requirements
* Working with Executive Director of Administration and Physician leadership to identify, justify and utilize requested resources in an efficient manner; assist with presentations to other PENN Medicine officials when required
* Interacting with ACC Business office and disease teams to assists with the oversight of effective and practical budgeting, billing, and monitoring of financial activity for clinical trials.
* Providing leadership to coordinate activities between budgeting and contracting, and financial execution ensuring compliance with sponsored and third party insurance billing.
* Working with ACC business office and Office of Research Billing Compliance to ensure appropriate financial training and distribution of proper communication.
Qualifications: * Requires a Bachelor's degree with 7-10 years of pharmaceutical industry/Clinical Operations experience, or an MS with at least 5-7 years of pharmaceutical industry/Clinical Operations experience, or equivalent combination of education and experience.
* Requires a minimum of 5 to 7 years of experience in clinical research related activities (e.g., monitor, study coordinator, or similar experience) and a 5-7 year proven record in Clinical Operations activities. An in-depth knowledge and experience in the application of Good Clinical Practice (GCP) regulations is required (e.g., ICH, FDA, NIH/NCI, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is needed.
* 5 or more years of staff supervisory experience required.
* Possess strong interpersonal, oral and written communication skills in order to effectively and independently oversee clinical operations and communicate results.
* Strong ability to demonstrate diplomacy and negotiation skills, as well as the ability to persuade when necessary.
* Able to confidently interact with all levels of management including senior management, PI's and others.
* Ability to develop interdepartmental relationships and form solid collaborations is critical.
* Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics.
Reference Number: 40-26558
Salary Grade: 030
Employment Type: Exempt
Org: CC-Cancer Center
Job Family: B-Executive/Managerial Administration