The Clinical Research Manager designs, plans and directs administrative, regulatory, personnel, clinical, and financial operations for the Memory and Aging Center Alzheimer’s Disease and Frontotemporal Dementia Clinical Trials Program. The Clinical Research Manager will work closely with senior management, including Principal Investigators, the Program Director, and Department leadership, to develop long and short term strategies to carryout the goal of developing effective treatments for Alzheimer’s Disease, Progressive Supranuclear Palsy, Frontotemporal Dementia and other related disorders.
Directs subordinate managers and staff in order to achieve broadly stated objectives. The Clinical Research Manager has an expertise in the operations of clinical trials, and functions with a high degree of autonomy in executing research for this large research program. Department Description: The UCSF Edward and Pearl FeinMemory and Aging Center (MAC) is an NIA-designated Alzheimer’s Disease Research Center (ADRC) and an international leader in the field of memory disorders, dementia and other conditions such as progressive supranuclear palsy.
The center houses 38 faculty members with specialists from a wide variety of disciplines, including neurology, neuropsychology, geriatrics, geriatric psychiatry, pharmacy, nursing, social work and speech pathology. The team investigates the clinical (neurological, cognitive, behavioral, neuroanatomic) characteristics of various neurodegenerative diseases. The Primary Investigator’s (PI) research within the MAC focuses on the decision-making processes in patients with frontotemporal dementia (FTD), Alzheimer's Disease (AD), primary progressive aphasia (PPA), and other neurodegenerative disorders.
The Memory and Aging Center also provides comprehensive evaluations for the diagnosis and treatment of patients, conducts research on new therapies including observational, supportive, and interventional opportunities, and offers support groups for patients, family members and friends. The group is committed to the mission of providing the highest quality of care for individuals with cognitive problems, conducting research on causes and cures for degenerative brain diseases, and educating health professionals, patients and their families.
To further engage in this work, the center collaborates with organizations such as the Alzheimer’s Disease Research Center (ADRC), Bluefield Project to Cure Frontotemporal Dementia, California Alzheimer’s Disease Center, Global Brain Health Institute, and the Tau Consortium. Responsibilities % of time Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 20 yes Responsible for achievement of clinical research objectives.
Provides operational, clinical, and administrative leadership, direction and oversight for all clinical research operations. Maintains the integrity of clinical research and ensures participant safety through management and oversight of staff. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements. 20 yes Interprets and applies all relevant scope of practice standards to develop clinical research processes, policies and guidelines.
Responsible for overall implementation and compliance of research program. Evaluates new research trials for financial and operational feasibility. Works with Program Director to determine appropriate staffing levels based on operational needs.
Develops strategies including methods and techniques to achieve the goals of the study and assure that standards are met. Develops systems and supervises Regulatory Specialist to ensure IRB submissions, monitor visits, study start-up, and regulatory files are managed in a timely, efficient manner. Develops trial and overall research evaluation strategies.
Manages action plan(s) when standards are not met. 15 yes Manages program resources and oversees resource management. Develops systems to ensure program receives correct revenue from sponsors based on work completed. Accountable for overall administrative planning and coordination of resources.
Works with upper management, team members, sponsors, department, and Clinical Trials Office to develop study budgets. Presents program budgeting projections to leadership and develops short and long term financial plans. 5 yes Regularly interacts with senior management on matters concerning clinical research for the Clinical Trials Program, including controversial situations, negotiations, or issues that require influencing or persuading others in order to move clinical research agenda forward.
Actively promotes the role of clinical research within the organization and in other institutions and committees. Represents the department to the industry and the community via participation in national and international meetings and professional groups. 30 yes Approves salary actions, promotions, hires, reclasses, and terminations. Develops plan for onboarding and training new team members.
Supervises research team, including regulatory/finance/admin specialists and clinical research coordinators. Reviews personnel actions, evaluates performance, and ensures compliance with HR standards including the most complex, sensitive disciplinary actions. Approves or rejects staffing requests, justifying how staffing patterns meet department needs.
Develops employee evaluation processes that meet organization standards. 10 yes Develops standards for training, supervising, and evaluating employees that also meet organization standards. Includes critical training focus on participant safety, regulatory compliance, and research ethics for team members. Identifies the need for continuing education programs for staff, such as best practices for working with participants with cognitive and behavioral issues. 0 0 0 0 0 0 100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9.
The total sum should add up to 100%.) Required
Master's degree in related area and / or equivalent experience / training. Minimum requirements of eight years related experience including at least seven in a lead/supervisory role. In depth academic knowledge and applied background in clinical research philosophy as evidenced by at least 2 years of experience successfully running complex clinical research trials.
In depth knowledge of clinical research and drug development concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. In depth theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research. At least 2 years of experience managing a team and supervising employees Excellent ability to establish collegial and productive relationships with prominent clinical investigators, research partners, industry and key opinion leaders in relevant therapeutic areas in order to develop and apply the strategic intent of the study.
Excellent skills to work collaboratively and act persuasively in sensitive situations; skills in conflict management techniques. Excellent ability to quickly evaluate complex issues and identify multiple options for resolution. Takes initiative and responsibility.
Able to solve problems when no precedent exists.
Certified Clinical Research Professional Registered Nurse At least 2 years experience working with patients with dementia or other neurodegenerative disease and experience managing clinical trials in an academic research setting Advanced practice nursing certifications and Basic Life Support Certified Clinical Research Professional
Full time · Day shift