Clinical Research Navigator

Clinical Research Navigator

Req ID: 147601
Location: Irvine, California
Division: School of Medicine
Department: SOM Office of Research
Position Type: Full Time
Salary Range Minimum: USD $97,000.00/Yr.
Salary Range Maximum: USD $182,200.00/Yr.

Who We Are

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. 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's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

The School of Medicine Office of Research supports basic, clinical and translational research endeavors in the School of Medicine. Our mission is to further research to enable discoveries and innovation for improved diagnostics and analytics and to enhance prevention, treatment and cures for patients.

Your Role on the Team

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.

What It Takes to be Successful

Required:

• 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.

Preferred:

• 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