Clinical Research Manager - Hybrid

About the role

The Clinical Research Manager (CRM) reports to an Assistant Director for the Clinical Trials Unit, responsible for all clinical research matters. This role supports the mission of the Chao Family Comprehensive Cancer Center (CFCCC), University of California Irvine School of Medicine, and the overall UC Irvine Health enterprise.

Responsibilities

• Lead one or more disease site(s) providing direct oversight and supervision to the disease team consisting of clinical research, research data, and/or long term follow-up coordinators.
• Analyze and solve problems, interpret policies, and serve as a subject matter expert in the disease area and team.
• Serve as a liaison to sponsors, governing agencies, and facilitate communication with national cooperative oncology groups, pharmaceutical companies, and other research entities as needed.
• Manage and coordinate a large portfolio of complex oncology clinical studies, ensuring adherence to protocols and compliance with industry and federal sponsor data entry requirements.
• Oversee auditing and monitoring visits, ensuring the team adheres to protocols and maintains high standards of work.
• Supervise, administer, and achieve operational goals and objectives for implementation within the specific disease team(s).
• Lead on-going training and education of Clinical Research Coordinators (CRCs), manage pre-study site selection visits, and oversee quality assurance and quality improvement goals and objectives through routine audits.

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.
• 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.
• 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.
• Preferred: 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.