Clinical Research Coordinator

University of California, Irvine•Irvine, CA

20d•Hybrid

About The Position

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. Independently or under the supervision of the Clinical Research Supervisor, Clinical Research Manager, and the Assistant Director of Clinical Research Operations, the incumbent leads the day-to-day execution of assigned clinical trials in the UCI Center for Clinical Research (CCR). Serving as primary coordinator on trials of varying complexity, the incumbent is accountable for accurate execution, documentation, and communication for comprehensive coordination and data management of complex phase I – IV clinical research protocols from initiation through close-out of research projects with human subjects. The incumbent operates in an interdisciplinary model across multiple therapeutic areas. This position facilitates all implementation phases of new clinical research studies as well as the ongoing coordination and maintenance of open and closed studies. Incumbent will conduct interviews with study patients in the clinic, screen participants, facilitate patient care, and collect data in compliance with established study protocols. The incumbent will receive appropriate onboarding and training to ensure proper preparation for this role as well as ongoing training where appropriate. 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)/ International Conference on Harmonization (ICH) guidelines, internal standard operating procedures (SOPs), FDA regulations, and University policies and procedures. This position plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies and meeting enrollment and retention goals. Complete timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments. This includes responsibility for the compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC). S/he will 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. The incumbent is also responsible for maintaining 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. This individual will interact with subjects, clinic and research staff, laboratory staff, radiology staff and any other medical professionals associated with our clinical research protocols. In addition, this individual must maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies. The main CCR offices and clinics are located at the UCI Medical Center in Orange and the UCI campus in Irvine, as well as various clinics at community sites throughout Orange County. The incumbent will be required to work at both main locations in Orange and Irvine, and sometimes community sites depending on responsibilities and scheduling demands.

Requirements

Ability to establish and maintain effective working relationships across the Health System
Ability to maintain a work pace appropriate to the workload and adapt to a rapidly changing work environment
Must demonstrate customer service skills appropriate to the job; ability to interact with patients and caregivers in a compassionate and empathetic manner
Excellent written and verbal communication skills in English
Must possess the skill, knowledge and ability essential to the successful performance of assigned duties
Proven ability to research, properly evaluate information, and prepare clear, concise and well-organized reports, summaries, and correspondence; ability to think critically, compile data from various sources, analyze and synthesize data/information and present it to others in a clear and concise way
Proven organizational skills and attention to detail; ability to multi-task, 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; proactive problem-solving abilities and follow through
Proven ability to independently exercise discretion and sound judgment
High level of integrity and honesty in maintaining confidentiality
Proven ability to maintain flexibility and adaptability; demonstrate teamwork, cooperation, self-control, and flexibility to get the work done
Proven ability to establish and maintain files and records
Working knowledge of computer software including Microsoft Office (Word, Excel, and Adobe Acrobat)
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
Ability to read and understand clinical trial protocols
Understanding of FDA regulations, GCP/ICH guidelines, and applicable clinical trial regulations
Working knowledge of current protocols and internal SOPs
Familiarity with medical terminology and medical/clinical environment
Demonstrated strong data management skills and attention to detail.
Demonstrated ability to provide excellent customer service experience for patients; responding to patient needs in a timely manner.
Demonstrated ability to interacts with patients and caregivers in a compassionate and empathetic manner.
Bachelor’s degree in related area or equivalent combination of education and/or equivalent experience
A minimum of 3 years of related work experience as a clinical research coordinator (CRC) or an assistant CRC
Demonstrated track record of human subjects 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
Must be able to provide proof of work authorization

Nice To Haves

Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored); knowledge of clinical trial federal, state and local regulation requirements
Professional certification through SOCRA or ACRP

Responsibilities

Leads the day-to-day execution of assigned clinical trials.
Serves as primary coordinator on trials of varying complexity.
Accountable for accurate execution, documentation, and communication for comprehensive coordination and data management of complex phase I – IV clinical research protocols.
Facilitates all implementation phases of new clinical research studies.
Conducts interviews with study patients in the clinic, screens participants, facilitates patient care, and collects data.
Develops and establishes processes for review and oversight of clinical trials.
Assists the Principal Investigator (PI) in recruiting patients for clinical studies and meeting enrollment and retention goals.
Completes timely and accurate collection and coordination of data submission to study sponsors.
Compiles and transcribes research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC).
Manages and collects accurate data and assists Principal Investigators and study coordinators for all data management aspects of non-cancer related trials.
Maintains communication with all elements of a multi-level research network.
Interacts with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
Interacts with subjects, clinic and research staff, laboratory staff, radiology staff and any other medical professionals associated with clinical research protocols.
Maintains clinical trial information in the clinical trial management system (OnCore).
Adheres to institutional policies.