University of California – Irvine Health Hiring for Assistant Director, Clinical Trials Unit – Hybrid at Irvine, CA  Full Time

Job Opening ID: 57400

Working Title: Assistant Director, Clinical Trials Unit – Hybrid

Department: Cancer Center

Bargaining Unit: 99

FLSA: Exempt

Payroll Job Code: 006571

Job Location: UCI Med Center-Orange

Percent of Time: 100%

Work Schedule: 8-5, M-F

Employee Class: Career

The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose mission is to promote and enhance cancer-relevant research, education, and patient care at UC Irvine. The CFCCC conducts interdisciplinary and transdisciplinary research into the causes, prevention, therapy, and survival of cancer, trains the next generation of cancer investigators and care providers, serves as a community and regional resource for state-of-the-art information and expertise on cancer, and delivers the highest-quality multidisciplinary care to cancer patients and their families within our catchment area. To facilitate this, the CFCCC provides research resources to its cross-institutional members engaged in this research. The Sue and Ralph Stern Center for Cancer Clinical Trials and Research (Stern Center) within the CFCCC provides centralized services for protocol review and monitoring, regulatory affairs, quality assurance, clinical research finance, and study management, coordination with internal and external partners on study financial terms and arrangements, and oversees accounts receivable, financial projections and reporting on clinical studies. The CTU manages industry-sponsored, institutionally sponsored, externally peer reviewed, and national group interventional clinical trials.

The Assistant Director for the Clinical Trials Unit (Asst. Dir. CTU) reports to the Administrative Director for Clinical Research Operations (Stern Center) for operational oversight and management of the Clinical Trials Unit (CTU) teams. S/he is responsible for leading all clinical research disease and lab teams and managing an exceedingly large clinical research portfolio, fulfilling the mission of the Chao Family Comprehensive Cancer Center (CFCCC), the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. The Asst. Dir. CTU is responsible for directing, administering and achieving operational goals and objectives in line with the CFCCC’s strategic plan and institutional strategic priorities. The individual will be responsible for leadership and overall facilitation of operational improvements and will work collaboratively with Principal Investigators engaged in clinical research, clinical cancer operations staff, clinical research coordinators, research accounting/finance staff, and other ancillary departments (e.g. Laboratory, Pathology, Radiology, Investigational Drug Service, etc.). The individual must be proactive in identifying and leading operational efficiencies for clinical trial workflow in keeping with quality assurance principles and implement the necessary quality control methods and tools that will enhance and support the work of clinical research teams. These improvements will include the implementation of best practices in developing innovative clinical trials, a plan to proactively detect, eliminate and prevent compliance issues, and strategizes for highly function clnical trial disease teams. S/he will focus on minimizing institutional risk, improving research subject safety, and maximizing cost recovery. This role is critical to ensuring an efficient, high-quality and successful operation across the clinical trial lifecycle of the full CFCCC portfolio. The individual works cooperatively with representatives from federal agencies, the pharmaceutical industry and other research organizations and interacts with intra-institutional faculty and staff. The incumbent works collaboratively across UCI’s research community in further developing, implementing, and leading the conduct of all clinical trials managed within the CFCCC. Manages operations, including administrative and budget operations, for a clinical research initiative or clinical research program. Receives research objectives and defines subordinate goals in order to achieve those objectives.

$111,200.00 – $215,000.00 (Annual Salary)

10 years of relevant work experience with a Bachelor of Arts/Bachelor of Science; or 5 years of relevant work experience with a Masters of Arts/Masters of Science; or equivalent experience

Master’s degree in related area and / or equivalent experience / training.

Advanced practice nursing certifications, particularly in Public Health, Emergency Nursing and Basic Life Support

Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a trial setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials. Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research. Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues. Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities. Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade. Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution. Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings. Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial. Expert user of the campus’ clinical information and documentation application programs. Technical proficiency in project management software.

Registered Nurse preferred

Experience overseeing oncology clinical research Familiarity with NCI Cancer Center Support Grant guidelines Experience working in OnCore Clinical Trials Management System (CTMS) Experience working in a multidisciplinary matrixed work environment

Travel to Irvine campus and satellite work sites as needed.

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 – https://hr.uci.edu/new-hire/conditions-of-employment.php

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 [emailprotected].

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