Supervisor, Study Startup and Regulatory

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

The UCI Alpha Clinic provides the necessary infrastructure, clinical and operational expertise to accelerate cell and gene therapies at UCI and throughout our communities. To accomplish our mission, we are working to achieve the following five goals:

1. Creating a Center of Excellence for cell-based therapeutics that addresses the unique challenges of testing and delivering novel cell therapies by integrating and building upon the extensive experience and many strengths of UCI and our partners.
2. Building interactive and highly trained teams and electronic data sharing systems to accelerate and translate discovery to improve human health.
3. Transforming the delivery of cell and gene therapeutics through our proven Good Manufacturing Practice (GMP) manufacturing.
4. Advancing, expanding, and integrating educational opportunities to inform patients, families, communities, and clinicians of the full range of scientifically sound and medically appropriate, regulated cell and gene therapy clinical trials while providing objective information about potentially dangerous and unproven procedures.
5. Serving as a regional, national and international resource for evidence-based best practices in cell and gene treatments.

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.

The Supervisor, Study Startup and Regulatory is directly responsible for ensuring protocols are appropriately shepherded through the startup and regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional, state and federal guidelines.

The Supervisor, Study Startup and Regulatory 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 startup and regulatory arena. The Supervisor, Study Startup and Regulatory, is directly responsible for management of staff. The supervisory role is composed of work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and other HR-related functions.

The Supervisor, Study Startup and Regulatory recommends and implements policies and procedures based on federal and state agency regulations for relevant compliance area. They provide leadership to solve issues related to compliance committees (e.g. RSC, IRB, IBC, PRMC, etc.). They manage all issues related to relevant compliance areas. Serve as a liaison between the organization and federal regulators (e.g. FDA, OHRP, etc.). They receive assignments in the form of objectives and determines how to use resources to meet schedules and goals. Provides guidance to subordinates to achieve goals in accordance with established policies. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

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.

Total Rewards

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

Conditions of Employment:

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

*Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Closing Statement:

The University of California is an Equal Opportunity Employer. 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 Anti-Discrimination Policy.

We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.