Clinical Research Navigator

University of California, Irvine•Irvine, CA

13d•Onsite

About The Position

The Clinical Research Navigator serves as a centralized expert resource for faculty conducting investigator-initiated clinical trials across the UCI School of Medicine (SOM). The Clinical Research Navigator provides resource navigation, regulatory training, audit readiness preparation, policy guidance, and operational coordination for the School’s IIT portfolio. This individual ensures study team awareness of—and operational planning for—federal regulations (FDA, OHRP), University of California policies, and institutional standards, while facilitating high-quality, efficient trial conduct. The Clinical Research Navigator works in close collaboration with Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and other research support services to promote compliant and streamlined trial execution.

Requirements

Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology.
Advanced knowledge of regulatory requirements.
Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment.
Adaptable to quickly changing priorities.
In-depth critical thinking skills to evaluate issues and identify a potential solution.
Creatively addresses complex or new problems.
Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills.
Clear and concise communicator.
Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members.
Works well with others to achieve common goals.
Proven ability to perform all commonly applicable functions in word processing and spreadsheet software.
Advanced knowledge of clinical information and documentation application programs.
Proven ability utilizing clinical trial management systems.
In-depth ability to work collaboratively with other cross-functional teams.
In-depth ability to interface, collaborate and influence / persuade other members of an extended study team.
Strong project management and cross-functional coordination skills.
Bachelor's degree in related area and / or equivalent experience / training
5–7+ years of progressively responsible clinical research experience.
Direct experience supporting investigator-initiated research protocols.
Must be able to provide proof of work authorization.

Nice To Haves

Experience in academic medical center environment.
Experience with ClinicalTrials.gov registration and results reporting.
Familiarity with IND/IDE submission processes.
Experience preparing for audits or inspections.
Experience with clinical trial management systems (e.g., OnCore).
Demonstrated knowledge of IRB processes and GCP standards.
Regulatory Affairs Certification (RAC) or CCRP/CCRC certification

Responsibilities

Serves as a centralized expert resource for faculty conducting investigator-initiated clinical trials.
Provides resource navigation, regulatory training, audit readiness preparation, policy guidance, and operational coordination for the School’s IIT portfolio.
Ensures study team awareness of and operational planning for federal regulations (FDA, OHRP), University of California policies, and institutional standards.
Facilitates high-quality, efficient trial conduct.
Works in close collaboration with Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and other research support services to promote compliant and streamlined trial execution.