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Hoag Health System · 12 hours ago

Clinical Research Coordinator II: Cancer Research

Irvine, CA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Hoag Health System is a nonprofit regional health care delivery network in Orange County, California, known for its commitment to providing high-quality health care services. The Clinical Research Coordinator II (CRC-II) is responsible for managing and coordinating clinical research activities, ensuring compliance with FDA regulations, and facilitating communication between study sponsors and participants.

Hospital & Health Care

Responsibilities

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

He/she will ensure accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting and scheduled subject follow-up visits

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

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

Qualification

Clinical Research CoordinationClinical PracticesFDA Regulatory GuidelinesData ManagementMedical TerminologyIATA CertificationACRP CertificationPhlebotomy CertificationProject ManagementAnalytical SkillsCommunication SkillsOrganizational SkillsInterpersonal SkillsAttention to DetailProblem-Solving Skills

Required

High School Diploma with 2-3 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

Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research