Clinical Research Coordinator

University of California, Irvine•Orange, CA

10d

About The Position

Independently or under the supervision of the Lab Research Manager (LRM) and the Sr. Clinical Research Coordinator of the Department of Orthopaedic Surgery, the incumbent is responsible for coordinating clinical trials in the Department of Orthopaedic Surgery. 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 processes 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 Orthopaedic Surgery 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

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.
Access to transportation to off-site clinical locations.
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, taking initiative and following through on assignments and ability to work as part of a team.
Proven ability to analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly.
Proven ability to independently exercise discretion and sound judgment.
High level of integrity and honesty in maintaining confidentiality.
Proven ability to maintain flexibility and adaptability.
Proven ability to establish and maintain files and records.
Working knowledge of computer software including Microsoft Office.
Proven ability to establish and maintain cooperative and collegial working relationships; demonstrated skill in interacting with the public, faculty and staff of various social, cultural, economic and educational backgrounds.
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
A minimum of 1 year 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

Nice To Haves

Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored).
SOCRA or ACRP Certification preferred

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
collect data in compliance with established study protocols
Develop and establish processes 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 of non-cancer related trials
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
accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies