Clinical Research Coordinator

Peregrine Team is hiring for a Clinical Research Coordinator in Irvine, CA. This position is a full-time, contract to hire role with full benefits and competitive pay.  

$35 - $40/hour

Job Duties: 

• Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator III (CRC-III) 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-III is responsible for managing complex Clinical Research trials including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government funded Clinical Research and investigator initiated Clinical Research.

• The CRC-III provides overall study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated Clinical Research trials.

• The CRC-III is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, and scheduled subject follow-up. 

• The CRC-III 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, and ensuring protocol required assessments are completed. 

• He/she ensures accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting, scheduled subject follow-up, and maintenance of regulatory binders. 

• The CRC-III may also assist with training other CRC’s within the team.

• The CRC-III will also work with Clinical Research Leadership and Institute leadership to develop and optimize processes between collaborating partnerships and operationalize and maintain operations for early therapeutics and other immunotherapy and other trials. 

• 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-III will record protocol specific assessments and treatments, ensure collection and shipment of samples, 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.

Qualifications: 

• High School Diploma - Required

• 4-6 years of Clinical Research Coordinator experience - Required

• Current ACRP or SoCRA Certification - Required

• Medical terminology - Required

• Bachelor’s Degree - Preferred

• Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines - Preferred

• Understanding of clinical trial methodologies and experience filing Institutional Review Board documents - Preferred

• International Air Transport Association (IATA) Certification - Preferred

• Shift: 40 hours- 5x8

Email your resume to careers@PeregrineTeam.com ASAP or apply here for consideration. 

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