Clinical Research Manager

Company: University of California - Irvine
Location: Orange
Posted on: May 10, 2025

Job Description:

Who We Are

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 . The Alpha Clinic (AC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance cell and gene therapy clinical research and activities at UCI. The UCI Alpha Clinic: * Is part of the California Institute for Regenerative Medicine (CIRM) Alpha Stem Cell Clinic network. * Promotes and facilitates scientific collaborations and interactions. * Provides centralized clinical research infrastructure support. * Accelerates the implementation of cell and gene therapy clinical research trials at UCI.
Your Role on the Team

Under the supervision of the Assistant Director of Clinical Research Operations, the Clinical Research Manager (CRM) supports the clinical research efforts of the Alpha Clinic (AC) by providing clinical team management for high-priority cell and gene therapy protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures. Primarily, the CRM will manage clinical trial activities for cell and gene therapy clinical trials. The incumbent will be responsible for managing clinical trial processes, checklists and templates for both standardization and ensure compliance with federal, state, and university regulations for the management and coordination for all investigator-initiated trials with sub-sites in collaboration with the Assistant Director, Clinical Research Operations. In addition, the CRM serves as a liaison to sponsors, governing agencies and facilities transmission of verbal and written communication to pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including compliance and regulatory groups such as the IRB, FDA, and sponsor monitors.
What It Takes to be Successful

Required:

• 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.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Bachelor's degree in related area and / or equivalent experience / training
• Clinical Trial Professional certification from a professional society within one year in position.
• 3-5 years' experience and expertise in Phase I, II and III clinical trials
• Experience managing cell and gene therapy clinical trials Preferred:
  • 5-10 years Clinical Research
  • Advanced degree preferredTotal CompensationIn 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 and . 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 EvaluationDetails of each policy may be reviewed by visiting the following page - Closing Statement:The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the University of California's Affirmative Action Policy please visit: . For the University of California's Anti-Discrimination Policy, please visit:. 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.
        Consideration for Work Authorization Sponsorship
        
        Must be able to provide proof of work authorization

Keywords: University of California - Irvine, Bell Gardens , Clinical Research Manager, Executive , Orange, California