Work Schedule: M-F, 8-5, May have to work some evenings and weekends.
Employee Class: Career
We are the University's center for aging and dementia research, with our faculty seeking to understand the causes leading to neurological disorders such as Alzheimer's disease.
The Regulatory Specialist ensures compliance with clinical and research study protocols that involve human subjects. This individual serves as the primary regulatory analyst and uses his/her expertise to serve as technical lead/guidance to management and Principal Investigators for human subject research studies at UCI MIND's Alzheimer's Disease Research Center (ADRC).
Master's degree in public health or related area preferred, with 3-5 years of experience in a clinical research environment.
Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements. Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals. Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems. In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team. Demonstrated experience with study initiation and ongoing coordination of human subjects, informed consent, and IRB submissions/regulatory documentation while maintaining protocol compliance. Experience working in a medical/clinical setting including organization and utilization of medical records, appropriate data extraction, and use of medical terminology. Experience with implementing systems/procedures to recruit and screen subjects for enrollment while tracking research subject utilization. Experience in research and data collection, and documentation. Ability to establish and maintain accurate files and records.
Knowledge of dementia in its different forms and a demonstrated interest in working with the elderly. Demonstrated experience with community outreach activities.
Special Conditions Required:
Occasional travel (local, domestic) may be asked. May have to work some evenings and weekends.
Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.
Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.