This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 10/08/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/18/19. 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 major initiative for Alzheimer's disease (AD) clinical studies, addressing treatments for both cognitive and behavioral symptoms.
The ADCS is a multi-center clinical trials consortium that provides an operational framework for large scale Alzheimer's disease research projects. The ADCS is a growing, progressive, multi-tiered organization which coordinates and manages approximately 10-15 different multi-center clinical trials at over 145 sites with federal and private grant and contract support. The type of studies that are managed by the ADCS range from Phase I through Phase III under IND(s) or IND- exemptions.
The Project Manager works under the Clinical Operations Director and the Alzheimer's Disease Cooperative Study (ADCS) Principal Investigator general supervision. Under a grant from the NIA, the Alzheimer's Disease Cooperative Study conducts multiple clinical trials related to Alzheimer's Disease, involving more than 2000 subjects. Research is conducted at multiple consortium member sites located at major educational institutions throughout the U.S., plus additional contracted sites. At participating sites each protocol has a study coordinator who is responsible for organizing and implementing the protocol.
The Project Manager resides at the ADCS and the functions are divided into 3 phases throughout the duration of each study 1) protocol implementation, 2) maintenance and 3) study close-out. The Project Manager will coordinate protocol implementation, develop database and protocol timeline, prepare and evaluate study needs, creation and distribution of procedure manuals and make vendor recommendations to management and Project Director, coordinate the protocol training meeting, develop the agenda and training manual.
Coordinate activities between groups throughout the study, ensure protocols are maintained and implement new procedures as needed. Provide necessary support to QA, Monitoring group, Team and study sites throughout the study. Serves as primary point of contact for ADCS and Industry teams, serving 7 Cores and ensuring team members are apprised of issues. The Project Manager will provide guidance to Project Coordinators, including project coordination, participate in developing, training and maintaining Standard Operating Procedures.
Theoretical knowledge of psychology such as typically acquired by a Bachelor's Degree in Psychology, Public Health, or related field; or equivalent educational and work experience required.
Experience in clinical research trials and clinical trial protocol development and implementation. Knowledge of clinical trials components including statistics, study methodology, informed consent, eligibility, and adverse events.
Demonstrated experience in clinical trials, neuropsychology, data management or related field.
Proven success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols. Experience with regulatory issues in clinical research.
A minimum of two (2+) years clinical trial experience as a study coordinator or equivalent. Familiar with basic medical research principles.
Strong project and time management skills. Proven organizational and multitasking skills. Ability to prioritize multiple responsibilities, set timelines, and manage projects including: planning, organizing, leading and controlling aspects for successful project completion.
Excellent verbal, written, and electronic communication skills that facilitate professional, effective, and courteous interaction with a diverse population including employees, faculty, researchers, participants, and regulatory agencies.
Ability to effectively present information and recommendations effectively. Ability to research, gather and organize information to produce clear and concise reports and presentations using various resources.
Demonstrated knowledge of databases including design, development, management, and usage. Understanding of relational and object oriented databases, data and file types, and user inte
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