Assistant Director, Clinical Trials Unit - Hybrid - 49593-1A

Job Opening ID: 49593

Reports To: Administrative Director of Clinical Research Operations

Working Title: Assistant Director, Clinical Trials Unit - Hybrid

Department: Cancer Center

Bargaining Unit: 99

FLSA: Exempt

Payroll Job Code: 009547

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 goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. 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, 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 with a clinical research portfolio of approximately 240 open trials.

 

The Assistant Director for the Clinical Trials Unit (Asst. Dir. CTU) reports to the Administrative Director of Clinical Research Operations (Stern Center) for operational oversight and management of the Clinical Trials Unit (CTU). S/he is responsible for leading all clinical research teams and managing a 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 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, and a plan to proactively detect, eliminate and prevent compliance issues. 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 intrainstitutional 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.

 

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.

 

$87,200.00 - $163,600.00 (annual)

 

 

9-10 years of relevant work experience with a Bachelor of Arts/Bachelor of Science or 3- 5 years of relevant work experience with a Masters of Arts/Masters of Science, or equivalent experience

Bachelor's degree in related area.

Clinical Trial Professional certification from a professional society within one year in position.

Skill in analyzing technical data, information and objectives; defining problems and needs; identify relevant issues, concerns, patterns, tendencies and relationships; formulating logical and objective conclusions; and recognizing alternatives and their implications Demonstrated ability to stay abreast of rapidly changing information from a wide range of sources and to incorporate it into policies and processes Experience in precise, predictive short- and long-range resource planning management within a fluctuating environment Demonstrated ability to apply and implement creative solutions to complex problems Demonstrated ability to conduct comprehensive, detailed analyses of complex policies, regulations, statutes and guidelines and to interpret and explain these to others Strong project planning/management experience Experience working in a Clinical Trials Management System (CTMS) Demonstrated experience supervising staff in a clinical research environment. Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research. Knowledge of pertinent policies, procedures, regulations and requirements of State, Federal, and other agencies Excellent interpersonal, organizational and time management skills Ability to work both independently and as part of team Ability to take initiative and demonstrate strong commitment to duties Ability to analyze problems, implement solutions and multitask Ability to work within a deadline-driven structure Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy Demonstrated experience in maintaining flexibility and adaptability while leading and implementing institutional change High level of integrity and honesty in maintaining confidentiality Foster and promote a positive attitude and professional appearance Expertise with Microsoft Office Suite (Word, Excel, Outlook, Powerpoint) Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems. Comprehensive knowledge of University policies and procedures related to clinical research administration Extensive understanding of the content and structure of a clinical research protocol Ability to establish and maintain cooperative working relationships with faculty, staff and external representatives Extensive experience with clinical research operations and management of the workflow of a large and complex clinical research portfolio

 

 

Advanced degree preferred.

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

 

 

Travel to Irvine campus and satellite work sites as needed

Must be able to successfully pass a DMV pull and must participate in the DMV pull program

 

 

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:

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

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 [email protected].