Clinical Research Coordinator

About the role

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. This position requires the incumbent to coordinate clinical trials in the UCI Center for Clinical Research (CCR).

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).
• 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.
• Compile and transcribe 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.
• Maintain 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.
• Maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies.

Requirements

• 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.
• Excellent written and verbal communication skills in English.
• 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 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.

Qualifications

• Preferred SoCRA or ACRP Certified.
• Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored).

Skills

• Computer software including Microsoft Office.

Benefits

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.