Clinical Research Coordinator III: Cancer Research - Newport Beach, CA, United States
1 day ago
Job description
DescriptionPrimary Duties And Responsibilities
- 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.
Education and Experience
- 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; and 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.
Preferred:
- 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
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