Clinical Research Manager

University of California, Irvine•Orange, CA

12h•Onsite

About The Position

Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Clinical Research Manager (CRM) is responsible for all clinical research operational matters in fulfilling the mission of CCR under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. Serving as an administrative and operational leader, the Manager oversees multiple Supervisors and their respective specialty units, and is accountable for unit-level operational effectiveness across multiple specialties and clinical locations. The Manager leads staffing models, hiring, onboarding, and workforce optimization, and addresses high-level operational challenges including coverage, call schedules, overtime, and investigator engagement. The Manager ensures appropriate senior and supervisory coverage for complex, inpatient, and nuanced research activities. The CRM involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures, good clinical practice, and regulations. May be responsible for finances, clinical operations, and site and vendor selection. The responsibilities are broad and diverse to include personnel management, physician relations, customer service, oversight of study patient screening and enrollment, tracking of clinical trial progress, compliance with regulatory standards, and the general oversight of the research process. Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio. Oversees unit operations to ensure compliance with departmental or organizational policies, procedures, and defined internal controls. Ensures accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental standards and procedures. Provides guidance to Clinical Research Supervisors overseeing and coordinating a large portfolio of complex clinical studies. This individual will initiate and maintain relationships with the research community, Health Systems, clinical research staff, investigators, external companies, academic leaders, as well as organizational executives. The Clinical Research Manager will 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. This individual orchestrates the long-term viability and growth of the institution's research programs by working closely with industry as well as physicians to participate in clinical trials that will benefit the community by leveraging the expertise of clinicians. The CRM serves as the liaison to sponsors, governing agencies, and facilitates transmission of verbal and written communication to national cooperative 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 and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The CRM guides the Clinical Research Supervisor in their responsibility to ensure 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 overseeing achievement of operational goals and objectives for implementation with each Supervisor. Additionally, the incumbent is responsible for leading ongoing training and education of CRCs, liaising with all appropriate administrative and medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) managing quality assurance and quality improvement goals and objectives through audit reviews of the team's portfolio. Work is primarily on-site across clinical locations. Remote work will only be approved with authorization from the Assistant Director.

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 Haves

Advanced degree preferred.

Responsibilities

personnel management
physician relations
customer service
oversight of study patient screening and enrollment
tracking of clinical trial progress
compliance with regulatory standards
general oversight of the research process
high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio
overseeing unit operations to ensure compliance with departmental or organizational policies, procedures, and defined internal controls
ensuring accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental standards and procedures
providing guidance to Clinical Research Supervisors overseeing and coordinating a large portfolio of complex clinical studies
initiating and maintaining relationships with the research community, Health Systems, clinical research staff, investigators, external companies, academic leaders, as well as organizational executives
plan, organize, lead, and monitor the scientific and clinical performance of research and ensure regulatory compliance
orchestrates the long-term viability and growth of the institution's research programs by working closely with industry as well as physicians to participate in clinical trials that will benefit the community by leveraging the expertise of clinicians
serves as the liaison to sponsors, governing agencies, and facilitates transmission of verbal and written communication to national cooperative groups, pharmaceutical companies, and other research entities as needed
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
guides the Clinical Research Supervisor in their responsibility to ensure 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
overseeing achievement of operational goals and objectives for implementation with each Supervisor
leading ongoing training and education of CRCs, liaising with all appropriate administrative and medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) managing quality assurance and quality improvement goals and objectives through audit reviews of the team's portfolio