Clinical Research Coordinator

University of California, Irvine•Orange, CA

About The Position

Under the direction of the Assistant Director of Clinical Research Operations, the Clinical Research Coordinator (CRC) will be responsible for supporting clinical research efforts of the UCI Alpha Cell Clinic by providing comprehensive coordination and data management of sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. The incumbent is responsible for supporting and coordinating all aspects of UCI Stem Cell Clinic trials and studies for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedule appointments, etc. Incumbent will conduct interviews with study patients in the clinic, screen participants, and collect data in compliance with established study protocol. Incumbent will ensure study protocols are followed, appropriate documentation is kept, and accurate data is collected. Incumbent will be responsible for the preparation and submission of study documents to the Institutional Review Board (IRB), Sponsored Projects Administration (SPA) and other regulatory committees. The CRC will also be responsible for interacting with the sponsor company and preparing for sponsor site monitoring visits or audits.

Requirements

Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others.
Demonstrated ability to organize and prioritize a complex and dynamic workload. Ability to multitask and meet deadlines, despite interruptions.
Ability to independently exercise discretion and sound judgment.
Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds.
Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands. Skill in working independently, taking initiative and following through on assignments.
Ability to think critically, compile data from various sources, analyze data, and prepare reports.
High level of integrity and honesty in maintaining confidentiality.
Strong attention to detail.
Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
3 to 5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience with a nationally-recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.).

Nice To Haves

Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly.
Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence.
Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships.
Foster and promote a positive attitude and professional appearance.

Responsibilities

supporting clinical research efforts of the UCI Alpha Cell Clinic
providing comprehensive coordination and data management of sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures
supporting and coordinating all aspects of UCI Stem Cell Clinic trials and studies for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping
assisting the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedule appointments, etc
conducting interviews with study patients in the clinic, screen participants, and collect data in compliance with established study protocol
ensuring study protocols are followed, appropriate documentation is kept, and accurate data is collected
preparation and submission of study documents to the Institutional Review Board (IRB), Sponsored Projects Administration (SPA) and other regulatory committees
interacting with the sponsor company and preparing for sponsor site monitoring visits or audits