This role is for a Clinical Research Manager to oversee all operational aspects of clinical research at the UCI Center for Clinical Research (CCR), under the UC Irvine School of Medicine. The manager serves as an administrative and operational leader, accountable for unit-level effectiveness across multiple specialties and clinical locations. The position involves leading staffing models, addressing operational challenges, and ensuring compliance with clinical study protocols and regulatory standards.
Responsibilities
Oversee all clinical research operational matters in fulfilling the mission of CCR
Serve as an administrative and operational leader, overseeing multiple Supervisors and their respective specialty units
Accountable for unit-level operational effectiveness across multiple specialties and clinical locations
Lead staffing models, hiring, onboarding, and workforce optimization
Address high-level operational challenges including coverage, call schedules, overtime, and investigator engagement
Ensure appropriate senior and supervisory coverage for complex, inpatient, and nuanced research activities
Develop and ensure compliance with clinical study protocols that involve human subjects
Oversee and resolve operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures, good clinical practice, and regulations
Manage personnel, physician relations, and customer service
Oversee study patient screening and enrollment
Track clinical trial progress
Ensure compliance with regulatory standards and the general oversight of the research process
Provide high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio
Oversee unit operations to ensure compliance with departmental or organizational policies, procedures, and defined internal controls
Ensure accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental standards and procedures
Provide guidance to Clinical Research Supervisors overseeing and coordinating a large portfolio of complex clinical studies
Initiate and maintain relationships with the research community, Health Systems, clinical research staff, investigators, external companies, academic leaders, as well as organizational executives
Interact with all levels of management, including the Dean’s Office of the School of Medicine and Office of Research, to plan, organize, lead, and monitor the scientific and clinical performance of research and ensure regulatory compliance
Orchestrate the long-term viability and growth of the institution's research programs by working closely with industry and physicians to participate in clinical trials
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Serve as the liaison to sponsors, governing agencies, and facilitate transmission of verbal and written communication to national cooperative groups, pharmaceutical companies, and other research entities as needed
Maintain 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
Guide Clinical Research Supervisors in ensuring team adherence to protocols, appropriate management and distribution of clinical research workload, CRC compliance with industry and federal sponsor data entry requirements, and overseeing auditing and monitoring visits
Oversee achievement of operational goals and objectives for implementation with each Supervisor
Lead ongoing training and education of CRCs
Liaise with all appropriate administrative and medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.)
Manage quality assurance and quality improvement goals and objectives through audit reviews of the team's portfolio
Requirements
Demonstrated experience working within complex organizational structures with strict policies and parameters
Knowledge of research design, research process, study budgets, and study implementation
Experience with study budgets, financial management, and billing oversight
Proven track record of personnel management including hiring, performance management, and staff development
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 with outstanding 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
Strong leadership, planning, and project management skills
Thorough understanding of FDA, GCP, and ICH guidelines
Thorough understanding of research compliance requirements
Expertise with Microsoft Office (Word, Excel, Outlook, PowerPoint)
Access to transportation to off-site research locations; travel to Irvine campus and satellite work sites as needed
Bachelor's degree in related area and/or equivalent experience/training
Research certification (ACRP, SoCRA, or equivalent) required
A minimum of 7 years of clinical research experience
Previous experience leading or supervising a team
Nice to have:
Advanced degree preferred
Benefits
Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Important Details
Schedule: Some after business hours and occasional weekends
Work format: Primarily on-site across clinical locations; remote work only with authorization from the Assistant Director
About the Company
UC Irvine, founded in 1965, is a member of the Association of American Universities and is ranked among the nation’s top 10 public universities. 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 is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. The UCI Center for Clinical Research (CCR) aims to improve health and wellness by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.
