Reporting to the Director, USA Health Mitchell Cancer Institute, with a dotted line reporting to the Senior Associate Dean, College of Medicine, the Director for USA Health Clinical Trials will be responsible for the strategic planning, administration, and operation of clinical trial activities for the University of South Alabama. The Director will work collaboratively with grants and contracts, finance, and research compliance offices to optimize operational procedures and infrastructure. The Director also will:
ensure policies and procedures are updated according to Good Clinical Practice guidelines,
ensure internal Quality Assurance standards and practices are in place,
oversee and manage clinical trial personnel to ensure compliance and success regarding recruitment and consent of participants onto clinical trials,
manage the annual budget for clinical trials infrastructure, and
manage resources in a responsible manner.
The Director will provide oversight, leadership, and guidance in the management and execution of trials. S/he will coordinate the efforts of internal and external resources to ensure timely scientific review, startup, patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality.
The Director will create SOP's and build an infrastructure for facilitation and management of clinical research; serve as a business development liaison with pharmaceutical industry for pipeline clinical trials; create and manage an educational and certification program for investigators and clinical nurse coordinators; provide updates and status reports to the Clinical Research Committee on a regular basis; develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators; manage the clinical research budget to responsibly oversee resource utilization; and interface with departments within and outside of the University.Master's degree in a natural or health sciences related field from an accredited institution as approved and accepted by the University of South Alabama and ten years of clinical trials experience, five of which were in a managerial capacity. Experience with all aspects of management of large clinical trials from inception to completion, knowledge of regulatory standards issued by FDA or other relevant agencies, experience with investigator initiated trials, knowledge of Good Clinical Practice, knowledge of and experience in experimental design, and basic understanding of statistics and statistical methods is required.
Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems
Expertise in searching medical literature and databases for clinical and technical information
Ability to forge cross-functional working relationships with internal teams and external project partners
Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of trials and resolve issues in a timely fashion
Superior writing skills and ability to effectively communicate with technical and non-technical people