This position is a limited position with the possibility of extension or career conversion.
Special Selection Applicants: Apply by 10/27/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a multi-center clinical trials consortium that provides an operational framework for large scale Alzheimer's disease research projects. The ADCS consists of 7 cores, 22 committees, 40 research sites that are members of the consortium/Steering Committee, and an additional 30 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS ranges from $15-$25M. The ADCS provides expertise in developing Alzheimer's disease related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH and clinical trial agreements with industry partners.
The Project Manager/Master Facilitator will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects for a multi-site clinical trial in Alzheimer's Disease (AD) that is being conducted both in long-term care facilities and also within the community for AD patients living at home with full-time caregiving. This position creates a bridge between the ADCS Coordinating Center (CC), ADCS academic sites within its network, long-term care facilities, and community clinics by working with staff within each entity to ensure constant and effective communication, and to resolve any challenges that arise in the trial's conduct. This includes, but is not limited to all aspects of study start-up and participant recruitment to ensure that trial milestones are met. Incumbent will work in tandem with CC clinical operations staff and cross-functional teams to streamline clinical trial conduct to ensure efficient recruitment of trial participants as well as streamlined workflows.
The Project Manager/Master Facilitator will also act as a liaison with other UCSD departments and agencies for the purpose of implementation of this trial and may also assist in additional studies as needed. The Clinical Research Project Manager/Master Trial Facilitator will plan, develop, and implement start-up procedures for research trials as well as lead, direct, and coordinate operational efforts. This role is also responsible for compliance with state and federal regulatory guidelines and contributes to the quality of the medical and clinical research data. This position also provides direction and guidance to clinical trials personnel, including Principal Investigators, staff, physicians, nurses, etc., conducting the trial across multiple settings and may interact with participant caregivers. The Master Trial Facilitator also provides educational and other information to the general public concerning the clinical trial.
The Clinical Research Project Manager/Master Trial Facilitator must be flexible and think creatively and strategically to anticipate trial roadblocks and resolve any arising issues quickly, as they are responsible and accountable to meet tight trial timelines. The incumbent will abide by federal and state regulations, GCP, HIPAA, and clinical trials best practices.
Bachelor's Degree basic science or social science such as Biology, Cognitive Science, Psychology, or a related field; and/or an equivalent combination of education and work experience.
Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.
Proven experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
Proven ability to find creative and innovative solutions to adjusting trial needs. Ability to be resourceful, creative, and strategic to anticipate potential roadblocks, think through challenges and provide recommended solutions.
Advanced skills to understand the overall nature of work/responsibilities to establish useful resources and contacts across multiple entities (academic centers, clinics, long-term care facilities, community outreach centers, etc.).
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.