Apply on Employer Site

Hoag Health System · 1 month ago

Clinical Research Coordinator II : DIGESTIVE DISORDERS

One Hoag Drive, Newport Beach, CA, 92663, US

Full-time

Onsite

Mid Level

$36.65/hr - $56.67/hr

Hoag Health System is a healthcare organization seeking a Clinical Research Coordinator II to oversee clinical research activities. The role involves managing FDA regulated clinical trials, ensuring compliance with protocols, and coordinating with various stakeholders to facilitate the research process.

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 managementClinical PracticesFDA regulatory guidelinesData managementInformed consent administrationCommunication skillsTeam collaboration