Senior Clinical Research Coordinator

University of California, Irvine • Orange, CA

4h

About The Position

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 Alpha Clinic (AC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance cell and gene therapy clinical trials and activities at UCI. The UCI Alpha Clinic:

• Is part of the California Institute for Regenerative Medicine (CIRM) Alpha Clinic network
• Promotes and facilitates scientific collaborations and interactions
• Provides centralized clinical research infrastructure support for cell and gene therapy clinical trials
• Accelerates the implementation of cell and gene therapy clinical trials at UCI

Your Role on the Team

Under the direction of the Assistant Director of Clinical Research Operations, the Senior Clinical Research Coordinator will be responsible for supporting clinical research efforts of the UCI Alpha Clinic (AC) 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 AC trials and studies for protocol specific requirements, research procedures, research chart preparation, data collection, subject study management and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, etc. 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.

Requirements

• Demonstrated high-level communication skills to convey information in a clear and concise way,synthesizing information and presenting it to others.
• 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.
• 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.
• Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships.
• 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.
• Foster and promote a positive attitude and professional appearance.
• Strong attention to detail.
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Experience with a nationally-recognized clinical research coordinator certification
• Bachelor's degree in related area and / or equivalent experience / training.
• 3-5 years

Nice To Haves

• Advanced degree (MA, MS, or MPH) preferred
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

Responsibilities

• supporting clinical research efforts of the UCI Alpha Clinic (AC) 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.
• supporting and coordinating all aspects of UCI AC trials and studies for protocol specific requirements, research procedures, research chart preparation, data collection, subject study management and record keeping.
• Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, etc.
• ensure study protocols are followed, appropriate documentation is kept, and accurate data is collected.
• responsible for the preparation and submission of study documents to the Institutional Review Board (IRB), Sponsored Projects Administration (SPA) and other regulatory committees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level