Hoag Health System · 9 hours ago
Clinical Research Coordinator I: Digestive Disorders
One Hoag Drive, Newport Beach, CA, 92658, US
Full-time
Onsite
New Grad, Entry LevelHoag Health System is a nonprofit regional health care delivery network in Orange County, California. They are seeking a Clinical Research Coordinator I who will be responsible for coordinating all aspects of clinical research activities, ensuring compliance with FDA regulations, and supporting study physicians and stakeholders.
Hospital & Health Care
Responsibilities
Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator I (CRC-I) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors
The CRC-I provides support, coordination for FDA regulated research including data, blood and tissue collection studies that may involve industry-sponsored, government funded and/or investigator initiated clinical research trials
The CRC-I is involved in all aspects of research clinical process including, but not limited to protocol review, preparation and administration of the informed consent, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, regular communication with study sponsors and their collaborators, and data entry into study systems within study required timeframes
The CRC I will ensure accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting, scheduled subject follow-up, and maintenance of regulatory binders
Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects
Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion)
In addition, the CRC-I will record protocol specific assessments and ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enters and clean data into study database while maintaining data quality
He/she will host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned
Performs other duties as assigned
Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research
Qualification
Required
High School Diploma with sufficient 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
Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research
Preferred
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
Current ACRP or SoCRA Certification
Company
Hoag Health System
Hoag is a nonprofit, regional health care delivery system in Orange County, California.
Founded in 1952
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Robert Braithwaite
President and Chief Executive Officer
Eric Cheung
Chief Legal Officer, General Counsel, Senior Vice President
Recent News
PR Newswire
2025-07-14
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