Clinical Research Coordinator

Who We Are

Founded in 1965,
UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.

It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

The UCI Center for Clinical Research (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.

Independently or under the supervision of the Clinical Research Supervisor, Clinical Research Manager, and the Assistant Director of Clinical Research Operations, the incumbent leads the day-to-day execution of assigned clinical trials in the UCI Center for Clinical Research (CCR). Serving as primary coordinator on trials of varying complexity, the incumbent is accountable for accurate execution, documentation, and communication for comprehensive coordination and data management of complex phase I – IV clinical research protocols from initiation through close-out of research projects with human subjects.

The incumbent operates in an interdisciplinary model across multiple therapeutic areas. This position facilitates all implementation phases of new clinical research studies as well as the ongoing coordination and maintenance of open and closed studies. Incumbent will conduct interviews with study patients in the clinic, screen participants, facilitate patient care, and collect data in compliance with established study protocols. The incumbent will receive appropriate onboarding and training to ensure proper preparation for this role as well as ongoing training where appropriate.

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)/ International Conference on Harmonization (ICH) guidelines, internal standard operating procedures (SOPs), FDA regulations, and University policies and procedures. This position plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies and meeting enrollment and retention goals.

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 of non-cancer related trials.

The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. This individual will interact with subjects, clinic and research staff, laboratory staff, radiology staff and any…