Clinical Research Coordinator III: Cancer Research

Hoag•Newport Beach, CA

18h

About The Position

Serve as a Clinical Research Coordinator III (CRC-III) responsible for all aspects of clinical research activities while collaborating with study physicians, inter- and intradepartmental stakeholders, and sponsors. Manage complex clinical research trials—including drug, device, and biologic studies—across industry-sponsored Phase I–IV trials, government-funded research, and investigator-initiated studies. Provide comprehensive study management, support, and coordination for FDA-regulated research: conduct protocol review, administer informed consent, recruit subjects, collect accurate data, complete case report forms (CRFs), report adverse events, and oversee scheduled subject follow-up. Oversee all facets of the clinical research process, including development of study treatment plans, completion of visit forms, and verification that all protocol-required assessments are performed. Ensure timely and accurate completion of CRFs, adverse event/serious adverse event (SAE) reporting, subject follow-up, and maintenance of regulatory binders. Assist with training other CRCs; collaborate with Clinical Research and Institute leadership to optimize processes, operationalize, and maintain early therapeutics, immunotherapy, and other trials. Develop study flow sheets; prepare source documentation; gather study data; assess subject eligibility; record protocol-specific assessments and treatments; coordinate sample collection and shipment; enter and clean data in study databases; host study team meetings; attend site-initiation visits (SIVs); and perform other duties as assigned.

Requirements

High School Diploma with 4-6 years of Clinical Research Coordinator experience
Demonstrated skills to successfully perform the assigned duties and responsibilities
Excellent verbal and written communications and presentation skills
Excellent organizational skills
Excellent interpersonal skills to work effectively in a diverse team
Attention to details
Proficiency with Microsoft Word, PowerPoint, and Windows
Excellent analytical and problem-solving skills
Ability to work effectively in a fast-paced, team-based environment
Project management and coordination skills
Ability to prioritize tasks and meet multiple deadlines on concurrent projects
Ability to establish cooperative working relationships with patients, co-workers, & physicians

Nice To Haves

Bachelor’s Degree or Equivalent
Current ACRP or SoCRA Certification
Medical terminology required
Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines
Understanding of clinical trial methodologies
Experience filing Institutional Review Board documents
Ability to abstract data from medical records and transfer it to data collection forms or directly into databases
International Air Transport Association (IATA) Certification

Responsibilities

Manage complex clinical research trials
Provide comprehensive study management, support, and coordination for FDA-regulated research
Conduct protocol review
Administer informed consent
Recruit subjects
Collect accurate data
Complete case report forms (CRFs)
Report adverse events
Oversee scheduled subject follow-up
Develop study treatment plans
Complete visit forms
Verify that all protocol-required assessments are performed
Ensure timely and accurate completion of CRFs
Ensure timely and accurate adverse event/serious adverse event (SAE) reporting
Ensure timely and accurate subject follow-up
Ensure timely and accurate maintenance of regulatory binders
Assist with training other CRCs
Collaborate with Clinical Research and Institute leadership to optimize processes, operationalize, and maintain early therapeutics, immunotherapy, and other trials
Develop study flow sheets
Prepare source documentation
Gather study data
Assess subject eligibility
Record protocol-specific assessments and treatments
Coordinate sample collection and shipment
Enter and clean data in study databases
Host study team meetings
Attend site-initiation visits (SIVs)