UC Irvine · 1 month ago
Clinical Research Manager
Orange County, CA
Full-time
Onsite
Mid, Senior Level
5+ years expUC Irvine is a prestigious member of the Association of American Universities, known for its academic achievement and innovative research. The Clinical Research Manager is responsible for overseeing clinical research operations, managing a team of coordinators, and ensuring compliance with regulatory requirements for oncology clinical studies. This role involves strategic support for clinical trials and maintaining communication with sponsors and regulatory bodies.
Higher Education
Responsibilities
Responsible for all clinical research matters in fulfilling the mission of CCR under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise
Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR’s clinical trial portfolio
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
Responsible for maintaining communication with all elements of a multi-level research network and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors
Supervises the day-to day management of a team of Clinical Research Coordinators (CRCs), Assistant Clinical Research Coordinators and Research Data Coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies
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
Responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific team
Directly responsible for the management of staff
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
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
Qualification
Required
Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters
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
Demonstrated skills in employee supervision and HR administration
Demonstrated experience in training others, particularly in the field of research
Critical thinking skills to evaluate issues and identify a potential solution
Clear and concise communicator; good verbal and written communication skills
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
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
Working knowledge of clinical protocol design, content and categories for inclusion in a final document
Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy
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
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
Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent
Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation
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
Skill in composing letters, preparing documents, and facilitating the production of materials
Extensive experience with clinical research and data collection methods
Ability to work within a deadline-driven structure
Experience in maintaining flexibility and adaptability while supervising and implementing institutional change
Willingness to work as a supportive, cooperative member of an interdisciplinary team
Foster and promote a positive attitude and professional appearance
Expertise with Microsoft Office (Word, Excel, Outlook, Powerpoint)
Bachelor's degree in related area
5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment
Preferred
Advanced degree preferred
SoCRA/ACRP certification preferred
Benefits
Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Company
UC Irvine
UC Irvine
10001+ employees
H1B Sponsorship
UC Irvine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (113)
2024 (86)
2023 (99)
2022 (76)
2021 (81)
2020 (79)
Funding
Current Stage
Late StageLeadership Team
Anand Gala
CEO Roundtable Member
Bob Romney
Chancellor's CEO Roundtable
Recent News
Business News: Pasadena Star-News
2025-12-29
2025-08-08
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