Clinical Research Manager - Hybrid

University of California, Irvine • Irvine, CA

15h • Hybrid

About The Position

The Clinical Research Manager (CRM) reports to an Assistant Director for the Clinical Trials Unit for all clinical research matters fulfilling the mission of the Chao Family Comprehensive Cancer Center (CFCCC), University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. The CRM leads one (or more) disease site(s) providing direct oversight and supervision to the disease team consisting of clinical research, reseach data, and/or long term follow-up coordinators. Responsible for analyzing and solving problems, intepreting policies and serve as subject matter expert in the disease area and team. Supervises staff to ensure accountability for compliance with research protocols and stewardship of the Department’s resources.

Serve as 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 and multi-discipinary 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 is responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific disease team(s).

The CRM supervises the day-to day management of a team of clinical research, research data, and/or long term follow-up coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies, and is responsible for staff performance management, and programmatic workflow of projects. Supervises and delegates staff assignments to meet clinical research goals and timelines, regulary meeting with team members to to ensure objectives are met while ensuring the quality and quantity of work are at appropriate standards and levels. 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 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 ancilliary 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.

Requirements

• Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.
• Demonstrated project management skills. 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 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.
• Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.
• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.
• Excellent 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 perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.
• Bachelor's degree in related area and / or equivalent experience / training
• Clinical Trial Professional certification from a professional society within one year in position.
• 5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment
• Experience at a NCI-designated Comprehensive Cancer Center

Nice To Haves

• Experience with clinical trial management systems, preferably OnCore
• Experience with Epic electronic medical record system
• Advanced degree preferred.
• Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored

Responsibilities

• Leads one (or more) disease site(s) providing direct oversight and supervision to the disease team consisting of clinical research, reseach data, and/or long term follow-up coordinators.
• Responsible for analyzing and solving problems, intepreting policies and serve as subject matter expert in the disease area and team.
• Supervises staff to ensure accountability for compliance with research protocols and stewardship of the Department’s resources.
• Serve as 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.
• Maintaining communication with all elements of a multi-level and multi-discipinary 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.
• Supervises the day-to day management of a team of clinical research, research data, and/or long term follow-up coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies, and is responsible for staff performance management, and programmatic workflow of projects.
• Supervises and delegates staff assignments to meet clinical research goals and timelines, regulary meeting with team members to to ensure objectives are met while ensuring the quality and quantity of work are at appropriate standards and levels.
• 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.
• Leading on-going training and education of CRCs, leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate ancilliary 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees