Hoag Memorial Hospital Presbyterian - Newport Beach, CA
posted 2 days ago
About the position
Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) 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-II provides study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials. This may include blood collection, data and trials that have therapeutic or device component. The CRC-II ensures smooth, accurate process of clinical studies from the planning, implementation, and post-study closure procedures. The CRC-II is involved in all aspects of the clinical research process included, but no limited to protocol review, preparation and administration of the informed consent, development of study treatment plans, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, and regular communication with study sponsors and their collaborators. 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. 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-II will record protocol specific assessments and treatments, 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. I. He/she will host study team meetings, attend site initiation visits (SIVs) and perform 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.
Responsibilities
- Provide study management, support, and coordination for clinical research trials.
- Ensure smooth and accurate processes of clinical studies from planning to post-study closure.
- Conduct protocol review and prepare informed consent.
- Develop study treatment plans and complete study-related visit forms.
- Ensure protocol-required assessments are completed per study guidelines.
- Process lab samples per IATA standards.
- Communicate regularly with study sponsors and collaborators.
- Discuss research studies with potential subjects and obtain informed consent.
- Develop study flow sheets and prepare study source documentation.
- Gather study data and assess subject eligibility.
- Record protocol-specific assessments and treatments.
- Ensure collection and shipment of samples.
- Complete study forms for submission to sponsors and agencies.
- Collect, enter, and clean data into study database.
- Host study team meetings and attend site initiation visits.
Requirements
- High School Diploma with 2-3 years of Clinical Research Coordinator experience.
- Excellent verbal and written communication skills.
- Excellent organizational and interpersonal skills.
- Attention to detail.
- 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 establish cooperative working relationships with patients, co-workers, and physicians.
Nice-to-haves
- Medical terminology knowledge.
- Working knowledge of FDA, NIH, and OHRP regulatory requirements.
- Understanding of clinical trial methodologies.
- Experience filing Institutional Review Board documents.
- Ability to abstract data from medical records.
- International Air Transport Association (IATA) Certification.
- Current ACRP or SoCRA Certification.
Benefits
- Equal Opportunity Employer.
- Commitment to a diverse work environment.
