Job detail

Clinical Research Coordinator II: Cancer Research

Hoag

#Medical Terminology #FDA Regulations #Clinical Research #Informed Consent #Case Report Forms #Immunotherapy #Regulatory Binders #Source Documentation #ICH GCP

Quick overview

The Clinical Research Coordinator III is responsible for managing all aspects of complex clinical research trials, including drug, device, and biologic studies, while collaborating with physicians and stakeholders. Key duties involve conducting protocol review, administering informed consent, recruiting subjects, ensuring accurate data collection, completing CRFs, and overseeing adverse event reporting and subject follow-up.

Requirements summary

A minimum requirement is a High School Diploma with 4-6 years of Clinical Research Coordinator experience, along with excellent communication, organizational, and interpersonal skills. Preferred qualifications include a Bachelor’s Degree, ACRP or SoCRA Certification, knowledge of FDA/NIH/ICH GCP regulations, and experience filing Institutional Review Board documents.

high schoolbachelor degreeCoordinationProject ManagementData EntryProcess OptimizationData CollectionCase Report Forms CompletionSubject RecruitmentAdverse Event ReportingData CleaningProtocol ReviewSite Initiation VisitsRegulatory Binders MaintenanceSubject Follow-upInformed Consent AdministrationStudy Treatment PlansSource Documentation Preparation

Job description

Primary 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.

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.

Clinical Research Coordinator II: Cancer Research

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