Clinical Research Coordinator

Clinical Research Coordinator

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.

The UCLA-UCI Alpha Stem Cell Clinic provides the necessary infrastructure, and medical and operational expertise to effectively and efficiently drive novel stem cell therapies to clinical trials and ultimately change clinical practice. To accomplish our mission, we are working to achieve the following five goals: creating a center of excellence for cell-based therapeutics that addresses the unique challenges of testing and delivering novel cell therapies by integrating and building upon the extensive experience and many strengths of UCLA, UCI, and our partners; building interactive and highly trained teams and electronic data sharing systems to accelerate and translate discovery to improve human health; transforming the delivery of cell therapeutics through our proven Good Manufacturing Practice (GMP) manufacturing; advancing, expanding, and integrating educational opportunities to inform patients, families, communities, and clinicians of the full range of scientifically sound and medically appropriate, regulated stem cell-based clinical trials while providing objective information about potentially dangerous and unproven procedures; serving as a regional, national and international resource for evidence-based best practices in stem cell treatments.

Your Role on the Team 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.

What It Takes to be Successful Required: 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.). Preferred: 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. Special Conditions: Flexible working hours required, may need to extend work hours into evenings and weekends on occasion