Clinical Research Manager- HYBRID - University of California, Irvine

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 www.uci.edu.

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 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 Clinical Research Manager (CRM) reports to, and is directly responsible to, the Assistant Director for the Clinical Trials Unit for all clinical research matters 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.
Serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to national cooperative oncology groups, 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 attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The CRM supervises the day-to day management of a team of Clinical Research Coordinators (CRCs), Assistant Clinical Research Coordinators and Assistant Research Data Coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies. The CRM is directly responsible for ensuring the team’s adherence to protocols, appropriate management and distribution of the clinical research workload, ensuring CRC compliance with industry and federal sponsor data entry requirements, and overseeing auditing and monitoring visits.

The CRM is responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific team. The CRM is directly responsible for the management of staff. The supervisory role is composed of staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions.

Additionally, the incumbent is responsible for leading on-going training and education of CRCs, leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial, managing quality assurance and quality improvement goals and objectives through routine audit reviews of the team’s portfolio.

Required:

• Experience with clinical trial management systems, preferably OnCore
• Extensive experience with clinical research and data collection methods
• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• Experience at a NCI-designated Comprehensive Cancer Center
• Working knowledge of clinical protocol design, content and categories for inclusion in a final document
• 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 establish and maintain cooperative working relationships with external sponsors, colleagues, faculty and staff. Excellent interpersonal, organizational and time management skills.
• Ability to work both independently and as part of team. Willingness to work as a supportive, cooperative member of an interdisciplinary team. Foster and promote a positive attitude and professional appearance.
• Clear and concise communicator; good verbal and written communication skills; both. Effective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, budgets and justifications which are clear, concise, logical and display syntax and grammar. Skill in composing letters, preparing documents, and facilitating the production of materials.
• 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. Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative Skill in performing a variety of duties, often changing from one to another with frequent interruptions Ability to work within a deadline-driven structure Ability to take initiative and demonstrate strong commitment to duties. Ability to act independently with demonstrated problem-solving skills, multi-task and to follow through on assignments with minimal direction.
• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters. Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy.
• Expertise with Microsoft Office (Word, Excel, Outlook, Powerpoint)
• Access to transportation to off-site research locations
• Critical thinking skills to evaluate issues and identify a potential solution. Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation. Experience in maintaining flexibility and adaptability while supervising and implementing institutional change.
• Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent
• Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored
• Clinical Trial Professional certification from a professional society within one year in position.

Special Conditions:

• Travel to Irvine campus and satellite work sites as needed

Total Compensation

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.

The expected pay range for this recruitment is $89,500- $1505,00 (Annual).

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. 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: https://policy.ucop.edu/doc/4010393/PPSM-20.

For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination.

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.