Supervisor, Study Startup and Regulatory

Your Role on the Team

Under the general direction of the Assistant Director, Research Operations of the Sue & Bill Gross Stem Cell Research Center for Clinical Research (SCRC), the Supervisor, Study Startup and Regulatory is responsible for all startup and regulatory matters in fulfilling the mission of Alpha Stem Cell Clinic and the overall UC Irvine Health enterprise. Provides high-level analytical support for strategic initiatives for the study startup and regulatory operations and implementations of ASCC's clinical trial portfolio.

The Supervisor, Study Startup and Regulatory independently directs and supervises the day-to-day management of critical startup and regulatory requirements for clinical research within ASCC and has primary responsibility for overseeing startup and regulatory affairs coordinators who are responsible for creating, negotiating, and monitoring budgets for clinical trials and grants, and regulatory coordination activities for UCI Alpha Clinic.

What It Takes to be Successful

Required:

• Thorough understanding of research administration guidelines of Federal and non-Federal sponsors supporting research and educational activities, preferably in a university environment.
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator; good verbal and written communication skills; both.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Thorough knowledge of applicable compliance requirements related to use of human or animal subjects in research, financial conflict of interest, biosafety, etc.
• Ability to manage significant volume of transactions.
• Ability to perform complex financial analysis and customized reporting
• Demonstrated competence in the use of spreadsheet and database software in financial analysis, fiscal management and financial reports.
• Ability to maintain independent judgment; strong organization and communication skills; and a customer service focus across broad and diverse subject areas
• Maintains current knowledge of compliance regulations in all areas of research administration.
• Demonstrated knowledge of generally accepted accounting, fiscal and reporting principles.
• Bachelor's degree in related area and / or equivalent experience / training
• Clinical Trial Professional certification from a professional society within one year in position.
• 5-10 years

Preferred:

• Demonstrated knowledge of effective grant funding processes, procedures and techniques
• Strong writing skills in a variety of styles to draft persuasive text for a variety of audiences while ensuring adherence to funding sponsor's guidelines.
• Advanced degree preferred.