Clinical Trials Coordinator - Impactful Research & Data

Overview 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 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. Responsibilities 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. Qualifications Required: 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 Preferred: 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 Special Conditions: May require study management coordination outside normal business hours May require travel to off-site research locations Afterhours support and coverage may be needed to adequately meet the needs of the research subject and/or adhere to the protocol requirements. Total Rewards In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits. Conditions of Employment: The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment: Background Check and Live Scan Employment Misconduct* Legal Right to work in the United States Vaccination Policies Smoking and Tobacco Policy Drug Free Environment *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements. California Child Abuse and Neglect Reporting Act E-Verify Pre-Placement Health Evaluation Details of each policy may be reviewed by visiting the following page - Closing Statement: The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy. We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr UCI group