Clinical Research Manager - Hybrid

Overview UC Irvine was founded in 1965 and is a member of the Association of American Universities. It is ranked among the nation's top public universities by U.S. News & World Report, with a campus recognized for premier research and innovation. The Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary organization focused on cancer research and patient care. The Sue and Ralph Stern Center for Cancer Clinical Trials and Research (Stern Center) provides centralized services for protocol review, regulatory affairs, quality assurance, clinical research business operations, and data management, managing a portfolio of active trials. To learn more about UC Irvine, visit Your Role on the Team The Clinical Research Manager (CRM) reports to an Assistant Director for the Clinical Trials Unit and fulfills the mission of the CFCCC, UC Irvine School of Medicine, and the UC Irvine Health enterprise. The CRM leads one or more disease sites, providing direct oversight and supervision to the disease team consisting of clinical research staff, research data personnel, and/or long-term follow-up coordinators. Responsibilities include analyzing and solving problems, interpreting policies, and serving as a subject matter expert in the disease area and team. Supervises staff to ensure compliance with research protocols and stewardship of resources. Serve as liaison to sponsors and governing agencies, and facilitate communication with national cooperative oncology groups, pharmaceutical companies, and other research entities as needed. Maintain communication with all elements of a multi-level, multi-disciplinary research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies (e.g., National Cancer Institute), and compliance and regulatory groups such as the Institutional Review Board (IRB), the Food and Drug Administration (FDA), and sponsor monitors. The CRM is responsible for supervising, administering, and achieving operational goals for the specified disease teams. The CRM supervises the day-to-day management of a team overseeing a large portfolio of complex oncology studies, including staff performance management and workflow coordination. Delegates staff assignments to meet clinical research goals and timelines, regularly meeting with team members to ensure objectives are met while maintaining quality and productivity. The CRM ensures adherence to protocols, appropriate workload distribution, CRC compliance with sponsor data entry requirements, and oversight of auditing and monitoring visits. The supervisory role includes staffing, work assignment, performance management, staff development, leave management, scheduling, and other HR-related functions. Additionally, the incumbent leads ongoing training and education of CRCs, manages pre-study site visits (PSSVs), liaises with ancillary units for trial conduct, and drives quality assurance and improvement through routine audits of the portfolio. What It Takes to be Successful Required: Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting. Demonstrated project management skills. Ability to manage multiple priorities, prioritize projects, and meet the demands of a fast-paced environment. Adaptable to changing priorities. Experience managing people with diverse educational backgrounds and skills. Strong management and conflict resolution skills to lead and motivate others. Experience in training others in research. Good problem-solving and analytical skills. Creatively addresses complex or new problems. Strong verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator with the ability to influence and negotiate. Excellent interpersonal skills, including teamwork, leadership, mentorship, and the ability to cultivate relationships with multiple stakeholders at various levels of administration. Ability to perform common word processing and spreadsheet tasks. Proficient with clinical information and documentation systems. Experience with clinical trial management systems. Ability to collaborate with cross-functional teams and coordinate programs with others in division, department, and organization. Bachelor's degree in a related field and/or equivalent experience/training. Clinical Trial Professional certification within one year in position. 5–7 years of experience with BA/BS or equivalent in an academic and/or research environment. Experience at an NCI-designated Comprehensive Cancer Center. Preferred: Experience with clinical trial management systems, preferably OnCore. Experience with Epic electronic medical record system. Advanced degree preferred. Extensive experience with various types of human subject clinical trials (e.g., National Group, Industrial, and Investigator-authored). Special Conditions Travel to satellite sites as needed. Total Rewards In addition to the salary range listed below, we offer a range of benefits, including medical insurance, sick and vacation time, retirement savings plans, and access to discounts and perks. Please review our compensation practices and benefits for details. Conditions of Employment The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. 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; have 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 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 at: 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 and creating inclusive, equitable environments. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, contact Human Resources at View phone number on click.appcast.io or View email address on click.appcast.io. Consideration for Work Authorization Sponsorship Must be able to provide proof of work authorization. #J-18808-Ljbffr University of California - Irvine