Temporary Clinical Research Coordinator (CRC)

University of California, Irvine•Irvine, CA

3d•$33

About The Position

This recruitment is for Temporary Full-Time Clinical Research Coordinator positions through UCI's internal temporary staffing service. Independently or under the supervision of the Clinical Research Manager and the Assistant Director of Clinical Research Operations, the incumbent is responsible for coordinating clinical trials. Incumbent is responsible for comprehensive coordination and data management of complex phase I – IV clinical research protocols from initiation through completion of research projects with human subjects. Incumbent will conduct interviews with study patients in the clinic, screen participants, and collect data in compliance with established study protocols. Develop and establish process for review and oversight of clinical trials conducted by investigators and ensure study protocols are followed, appropriate documentation is kept, and accurate data is collected according to Good Clinical Practice (GCP), internal standard operating procedures (SOPs), and University policies and procedures. Complete timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments. This includes responsibility for the compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC). S/he will work with the clinical research team to manage and collect accurate data and assist Principal Investigators and study coordinators for all data management aspects. Clinical research offices and clinics are located at the UCI Medical Center in Orange and the UCI campus in Irvine, as well as various clinics at community sites throughout Orange County. The incumbent will be required to work at both main locations in Orange and Irvine, and sometimes community sites depending on responsibilities and scheduling demands.

Requirements

A minimum of 3 years of related work experience as a clinical research coordinator (CRC) or an assistant CRC with a Bachelor’s degree or equivalent experience.
Demonstrated track record of human subjects research (Phase I, II, III drug trials, and device trials) coordination, informed consent procedures and documents, and IRB submissions.
Experience working in a medical/clinical setting and familiarity with medical terminology.
Bachelor’s degree in related area or equivalent combination of education and/or experience.
May require study management coordination outside normal business hours.
May require travel to off-site research locations.
Must possess and maintain a valid California driver’s license.
Position is subject to the California DMV’s “Pull Notice System” and continued employment is contingent upon proof of satisfactory driving record.

Nice To Haves

SOCRA or ACRP Certification preferred Special Conditions required for this Job.

Responsibilities

coordinating clinical trials
comprehensive coordination and data management of complex phase I – IV clinical research protocols from initiation through completion of research projects with human subjects
conduct interviews with study patients in the clinic, screen participants, and collect data in compliance with established study protocols
Develop and establish process for review and oversight of clinical trials conducted by investigators and ensure study protocols are followed, appropriate documentation is kept, and accurate data is collected according to Good Clinical Practice (GCP), internal standard operating procedures (SOPs), and University policies and procedures
Complete timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments
compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC)
work with the clinical research team to manage and collect accurate data and assist Principal Investigators and study coordinators for all data management aspects