REGULATORY AFFAIRS SUPERVISOR
University of California Irvine
REGULATORY AFFAIRS SUPERVISOR
Updated: Nov 16, 2020
Location: UC Irvine Campus
Department: UCI CTR FOR CLINICAL RESEARCH
Job Opening ID: 12909
Reports To: CLIN RSCH MGR 1
Working Title: Regulatory Affairs Supervisor
Department: UCI Center for Clinical Research
Bargaining Unit: 99
Payroll Job Code: 009548
Job Location: UCI Campus- Irvine
Percent of Time: 100%
Work Schedule: 8-5, M-F
Employee Class: Career
The UCI Center for Clinical Research is driven to improve the health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic. Built as an excellent clinical research program designed to serve our patients, community, investigators and partners with a high level of efficiency, integrity and quality. With hundreds of clinicians and researchers dedicated to innovating, accelerating, growing and inspiring new ways to address and treat disease. Their expertise gives us an edge in treatments and trials related to a full spectrum of conditions. Our devoted team of nationally regarded physicians and nurses, researchers and clinicians, educators and students are all united by a single calling - to improve the lives of the people in our community and beyond. We are unique in our ability to provide the most compassionate healthcare and research because we are driven by our passion for innovation, grounded in the best medical and scientific knowledge available.
Under the general direction of the Director of Clinical Research Operations in the School of Medicine - Center for Clinical Research (CCR), The Regulatory Affairs Supervisor (RAS) is responsible for all clinical research regulatory matters in fulfilling the mission of CCR under the University Of California Irvine School Of Medicine and the overall UC Irvine Health enterprise. Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio. The RAS independently directs and supervises the day-to day management of critical regulatory requirements for clinical research within CCR and has primary responsibility for overseeing regulatory affairs coordinators who are responsible for submitting protocols to clinical research committees [e.g. Institutional Review Board (IRB) and Clinical Research Acceleration and Facilitation Committee (CRAFT)]. The RAS is directly responsible for ensuring protocols are appropriately shepherded through the regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional, state and federal guidelines. The RAS is responsible for directing, administering, and achieving operational goals and objectives for the implementation and oversight of new operational strategies and unit goals within the regulatory arena. The RPM is directly responsible for management of staff. The supervisory role is composed of staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions.
$62,400.00 - $95,000.00
5 - 7 years of experience with BA/BS or equivalent experience years in regulatory oversight in an academic and/or research environment. Advanced degree and SoCRA/ACRP certification preferred.
Bachelor's degree in related area.
Clinical Trial Professional certification from a professional society within one year in position.
Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters. Demonstrated experience in supervising staff in research environment. Effective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, budgets and justifications which are clear, concise, logical and display syntax and grammar. Working knowledge of clinical protocol design, content and categories for inclusion in a final document. Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy. Ability to establish and maintain cooperative working relationships with colleagues, faculty and staff Excellent interpersonal, organizational and time management skills. Ability to work both independently and as part of team. Ability to take initiative and demonstrate strong commitment to duties. Ability to act independently with demonstrated problem-solving skills, multi-task and to follow through on assignments with minimal direction. Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent. Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation. Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative. Skill in performing a variety of duties, often changing from one to another with frequent interruptions. Skill in composing letters, preparing documents, and facilitating the production of materials. Experience with clinical research and data collection methods. Ability to work within a deadline-driven structure. Demonstrated experience in maintaining flexibility and adaptability while leading and implementing institutional change. Foster and promote a positive attitude and professional appearance. Expertise with Microsoft Office (Word, Excel, Outlook, Powerpoint) and financial software. Experience working in Forte's OnCore Clinical Trials Management System (CTMS). Experience working in a multidisciplinary matrixed work environment.
Advanced degree preferred.
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.
To apply, visit https://careersucirvine.ttcportals.com/jobs/5871066-regulatory-affairs-supervisor
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