Sr. Clinical Research Coordinator

University of California, Irvine•Irvine, CA

5d•Hybrid

About The Position

Under the supervision of the Director of Outcomes Research within the Susan Samueli Integrative Health Institute (SSIHI), the Senior Clinical Research Coordinator (SCRC) supports the clinical research efforts of SSIHI by providing comprehensive coordination and data management for complicated Phase I-IV protocols 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 the integrative health-related trials (Phase I-IV) 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. Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Center for Complementary and Integrative Health (NCCIH), and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The incumbent is responsible, under the direction of the Director of Outcomes Research, to provide training and guidance to other clinical research coordinators, demonstrating best practices, and providing ongoing analysis of internal processes and providing recommendations for new policies and procedures to improve overall operational efficiency and customer service. In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the NCCIH

Requirements

Ability to interact with the public, faculty, and staff
Ability to establish and maintain files and records
Access to transportation to off-site research locations
Willingness to work as a supportive, cooperative member of an interdisciplinary team
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, compiles data from various sources, analyze data, and prepare reports.
Ability to work both independently and as part of team
Ability to take initiative and demonstrate strong commitment to duties
Ability to perform ongoing needs analysis and recommend solutions to resolve concern.
Ability to work within a deadline-driven structure
Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change
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 integrative health research.
Current nationally-recognized clinical research coordinator certification (e.g. Association of Clinical Research Professionals (ACRP), etc.)
Knowledge with various types of human subject clinical trials i.e., National Group, industrial, and Investigator-authored.
Bachelor's degree in related area and / or equivalent experience / training.
Certified Clinical Research Professional through Association of Clinical Research Professionals (ACRP)
5 to 7 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
Must be able to provide proof of work authorization

Nice To Haves

Experience with clinical trial management systems, preferably OnCore.

Responsibilities

Support and coordinate all aspects of integrative health-related trials (Phase I-IV) for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping.
Attend clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, and schedule appointments.
Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to other research entities.
Maintain communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies (e.g., NCCIH), and compliance and regulatory groups (e.g., IRB, FDA, sponsor monitors).
Provide training and guidance to other clinical research coordinators, demonstrating best practices.
Conduct ongoing analysis of internal processes and provide recommendations for new policies and procedures to improve operational efficiency and customer service.
Accurately maintain clinical trial information in the clinical trial management system (OnCore).
Adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the NCCIH.