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Manager, Clinical Trials Unit

Company: UCI Health
Location: Irvine
Posted on: November 22, 2022

Job Description:

Job Opening ID: 45254 Reports To: Assistant Director of Clinical Research Operations Working Title: Manager, Clinical Trials Unit Department: Stem Cell Research Center Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: 009548 Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5, M-F Employee Class: Career Position Summary: The Alpha Stem Cell Clinic (ASCC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance stem cell clinical research and activities at UCI. The UCLA-UCI Alpha Stem Cell 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 clinical research trials. Under the supervision of the Assistant Director of Clinical Research Operations, the Manager, Clinical Trial Unit (CTU) supports the clinical research efforts of the Alpha Stem Cell Clinic (ASCC) by providing regulatory and clinical team management for high-priority stem cell-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures. Primarily, the CTU Manager will manage regulatory and clinical trial activities for stem cell clinical trials. Responsibilities related to regulatory coordination activities include independently managing and preparing submissions for new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees. Also, 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 incumbent will be responsible for managing regulatory and 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 of Clinical Research Operations arena. In addition, the CTU Manager 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. Compensation Range: $78,900 - $112,000 Department Website: Required: 5 to 7 years of related work experience in clinical research. Bachelor's degree in related area. Clinical Trial Professional certification from a professional society within one year in position. Critical thinking skills to evaluate issues and identify a potential solution. Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting. 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. Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research. 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. 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. Clear and concise communicator; good verbal and written communication skills; both. Preferred: Advanced degree preferred. Special Conditions Required: May require study management coordination outside of normal business hours. 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 * Legal Right to work in the United States * Vaccination Policies * Smoking and Tobacco Policy * Drug Free Environment 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 - Closing Statement: 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. 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 .

Keywords: UCI Health, Irvine , Manager, Clinical Trials Unit, Executive , Irvine, California

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