UCSD Layoff from Career Appointment: Apply by 04/05/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 04/15/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a candidate has been successfully identified.
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, 35 research sites that are members of the consortium/Steering Committee, and an additional 40 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. This position reports directly to the Director of Clinical Monitoring.
The Clinical Monitor Manager will provide leadership and direction for the ADCS Clinical Monitoring group (CRAs), which monitors multiple Alzheimer’s Disease research trials in various phases, at over 60 sites throughout the United States and Canada. The incumbent will supervise a group of on-site and East Coast (remote) clinical monitors in monitoring activities for multi-site clinical trials to ensure compliance with study protocols, HIPAA, internal SOPs, and GCP/ICH. Incumbent will provide effective leadership and close guidance in leading the development, execution, and governance of clinical monitoring standards, protocols, and tailor monitoring plans to each trials specific needs.
In addition, the incumbent will be responsible for making important original contributions pertaining to the clinical monitoring activities including strategically designating monitoring assignments to make most efficient use of the onsite and East Coast monitoring staff, setting priorities, goals, and objectives for the monitoring group, and developing strategies to meet goals, set expectations for individual monitors and manage performance accordingly. The incumbent will be accountable for deliverables and meeting timelines; collaborate effectively with other ADCS functional groups to carry out studies in various stages of development, maintenance, and closeout; facilitate various project meetings and conference calls and contribute original ideas. The incumbent will also be responsible for evaluating business needs, analyzing monitoring staff resources in conjunction with the Chief of Staff/Director of Administration, prioritizing workload, allocating resources to ensure appropriate assignment and fair distribution of workload, and for developing innovative solutions to improve monitoring processes.
Uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and/or action. Serves as a technical expert and advisor to department head.
Nine (9) years of related experience, education/training, OR a Bachelor’s degree in related area plus five (5) years of related experience/training. Prior managerial experience is preferred.
Relevant compliance certification, such as CITI training, GCP, HIPAA, required.
Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.
Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.
Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.
Strong proficiency in public speaking, and writing.
Minimum five (5) years experience in clinical research monitoring or a combination of at least five (5) years of monitoring and related clinical research experience as well as experience in supervising and managing others with demonstrated ability to set and meet goals, motivate others, and hold individuals accountable for deliverables is required.
Proven ability to build productive relationships with people of all types of backgrounds, personalities, and skill levels. Proven experience in supervision of personnel, including planning for staffing needs, establishing behavioral performance objectives and conducting constructive performance evaluations, and identifying performance related training needs.
Experience in clinical research trials and clinical trial protocol development. Knowledge of clinical trials components including statistics, study methodology, informed consent, eligibility, and adverse events. Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols. Experience with regulatory issues in clinical research.
Advanced theoretical knowledge and experience of the clinical research methods, protocol design, and ability to identify necessary resources and procedures to carry out successful implementation of the clinical study.
Demonstrated knowledge of FDA regulations, Good Clinical Practice Guidelines, and Standard Operating Procedures.
Strong leadership and management skills. Strong decision-making skills and ability to use independent judgment to quickly set priorities, solve problems and resolve conflict. Demonstrated ability to respond effectively to unexpected events and crises
Experience directing, organizing, and prioritizing workload to meet required deadlines and department objectives. Proven project management experience including forecasting, planning, organizing, and initiating action for successful project completion. Ability to perform effectively under conditions of fluctuating workload and frequent interruptions. Ability to work independently and prioritize tasks to meet strict guidelines and deadlines.
Strong knowledge and experience working with ICH, GCP, NIH, state and federal guidelines with ability to identify compliance issues.
Proven ability to create control systems to identify areas for improvement, and control unforeseen problems.
- Master's degree preferred.
- Clinical knowledge of Alzheimer's Disease, theoretical knowledge in Health Sciences or psychological science or equivalent combination of educational and work experience, especially pertaining to Alzheimer's Disease.
- Certification in Clinical Research (CCRC, CCRA, CCRP).
- Past managerial experience.
- Employment is subject to a criminal background check.
- Must be willing to travel up to 25% of the time, and be onsite at the ADCS when not traveling.
- Must be willing to work outside of normal business hours, including evenings and weekends to meet deadlines.
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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