Clinical Research Coordinator

Overview

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 (Use the "Apply for this Job" box below)..

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.

For this position you must be able to go into the office located in Orange, California.

Responsibilities

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 in the UCI Center for Clinical Research (CCR). 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 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. In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies.

The main CCR 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.

Qualifications

For this position you must be able to go into the office located in Orange, California.

Required:

* Bachelor's degree in related area or equivalent combination of education and/or experience.

* A minimum of 3 years of related work experience as a clinical research coordinator (CRC) or equivalent experience.

* Demonstrated track record of human subject's 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

* Ability to establish and maintain effective working relationships across the Health System.

* Ability to maintain a work pace appropriate to the workload.

* Must demonstrate customer service skills appropriate to the job.

* Excellent written and verbal communication skills in English.

* Must possess the skill, knowledge and ability essential to the successful performance of assigned duties.

* Proven ability to research, properly evaluate information, and prepare clear, concise and well-organized reports, summaries, and correspondence; ability to think critically, compile data from various sources, analyze and synthesize data/information and present it to others in a clear and concise way.

* Proven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently,…