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 trialsincluding drug, device, and biologic studiesacross industry-sponsored Phase IIV 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
Hoag Memorial Hospital Presbyterian is a nonprofit regional health care delivery network in Orange County, California, consisting of three acute-care hospitals with sixteen urgent care centers, eleven health centers and a network of more than1,800 physicians, 100 allied health members, 8,000 employees, and 2,000 volunteers. More than 30,000 inpatients and 550,000 outpatients choose Hoag each year.
For over 70 years, Hoag has delivered a level of personalized care that is unsurpassed among Orange County's health care providers. Since 1952, Hoag has served the local communities and continues its mission to provide the highest quality health care services through the core strategies of quality and service, people, physician partnerships, strategic growth, financial stewardship, community benefit and philanthropy.
Hoag offers a comprehensive blend of health care services including six institutes providing specialized care in the areas of cancer, heart and vascular, neurosciences, women's health, orthopedics, and digestive health through our institutes.
Hoag was the highest ranked hospital in Orange County in the 2024-2025 U.S. News &World Report, the only Orange County hospital ranked in the top 10 for California. The organization was ranked the #5 hospital in the Los Angeles Metro Area and the #10 hospital in California.
Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.
Job Identification 128120
Job Category Research
Locations 1 Hoag Dr, Newport Beach, CA, 92663, US
Pay Range $38.50-$59.48/hourly
Remote or Onsite Onsite
Job Schedule Full Time
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