This vacancy may also be filled by a Registered Nurse. Registered Nurses should apply to announcement number CBSX-11096430-21-MB. As the National Pharmacy Program Manager (Associate Center Director for the Division of Quality Assurance) you will serve as the Clinical Research Pharmacy Coordinating Center's (CRPCC) chief liaison with the Cooperative Studies Program (CSP) Biostatistical and Data Management Centers, CSP Epidemiology Centers, CSP Pharmacogenomics Laboratory, CSP Subdomain on Project Management, Director Clinical Science R&D (VACO), and CSP Director (VACO) regarding quality in all multicenter clinical trials CRPCC manages and supports. You will be the program's quality and regulatory liaison to the FDA, pharmaceutical industry and individual investigators in VA's Merit Review Program. You will oversee the sections dealing with Quality Assurance activities in a research and manufacturing facility, including the Quality Management Section, Integrated Quality Unit, Regulatory and Clinical Compliance Section, and the Biopharmaceutics/Pharmacokinetics Laboratory Section and Biorepository. Duties include, but are not limited to: Overseeing and participating in the implementation of ISO and performance excellence principles at the other Program Centers on a national basis. Expanding quality, operational, and performance excellence initiatives to other relevant CRPCC activities. Performing the full range of supervision for staff. Ensuring that the CRPCC has an effective quality management system that addresses customer focus, leadership, involvement of people, process approach, systems approach to management, continual improvement, factual approach to decision making, and mutually beneficial supplier relationships with the goal of producing effective services and products. Collaborating with the Center Director, Deputy Director, and other Associate Center Directors on a Center-wide policy and management issues. Participating in the CRPCC's educational programs, including direct involvement with Fellows, professional program and graduate pharmacy students. Overseeing and participating in the identification, development, and provision of education, orientation, and training for employees on the quality management system and quality assurance processes at the CRPCC and program level. Working closely with the Associate Center Director of the Division of Study Design and Management regarding the quality and regulatory issues related to the pharmaceutical aspects of clinical trials. Acting as Project Director and Clinical Research Pharmacist for assigned multicenter clinical trials including supervision of Pharmaceutical Project Manager and project teams. Participating in preparing manuscripts reporting the results of assigned national studies by serving as a member of the writing committee. Developing and reviewing draft protocols that support quality including Quality Control Procedures, Data Security Plans, Good Clinical Practice, and adverse event monitoring and reporting. Devoting a portion of time to individual research projects related to assigned studies, CSP, clinical research methodology, the practice of pharmacy, medical research, quality management, or performance excellence. Work Schedule: Monday - Friday, 8:00am-4:30pm Financial Disclosure Report: Not required
Internal Number: 599316500
About Veterans Affairs, Veterans Health Administration
Providing Health Care for Veterans: The Veterans Health Administration is America’s largest integrated health care system, providing care at 1,255 health care facilities, including 170 medical centers and 1,074 outpatient sites of care of varying complexity (VHA outpatient clinics), serving 9 million enrolled Veterans each year.