Clinical Research Coordinator III: Cancer Research

Hoag • Newport Beach, CA

11h

About The Position

Report to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations; serve as 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 and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• 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 and 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—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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED