UC Irvine
Clinical Research Coordinator at UC Irvine
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The University of California, Irvine (UCI) is a top research university founded in 1965, affiliated with the prestigious Association of American Universities and 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, UCI has more than 36,000 students and offers 224 degree programs. It is 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.
Seniority level:
Entry level
Employment type:
Full-time
Job function:
Research, Analyst, and Information Technology
Responsibilities
Coordinating clinical trials in the Department of Orthopaedic Surgery.
Comprehensive coordination and data management of complex Phase I–IV clinical research protocols from initiation through completion of research projects with human subjects.
Conducting interviews with study patients in the clinic, screening participants, and collecting data in compliance with established study protocols.
Developing and establishing processes for review and oversight of clinical trials conducted by investigators, ensuring study protocols are followed, appropriate documentation is kept, and accurate data is collected according to Good Clinical Practice (GCP), internal SOPs, and University policies.
Completing timely and accurate data collection and coordination of data submission to study sponsors, ensuring quality control and leading to timely milestone payments.
Compiling and transcribing research patient data and study‑related information into case report forms (CRFs) and sponsor‑specific electronic data capture systems (EDC).
Assisting Principal Investigators and study coordinators with all data management aspects of non‑cancer related trials.
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.
Accurately maintaining clinical trial information in the clinical trial management system (OnCore) and adhering to institutional policies.
Working at both main locations in Orange and Irvine, and sometimes at community sites depending on responsibilities and scheduling demands.
Qualifications
Ability to establish and maintain effective working relationships across the Health System.
Ability to maintain a work pace appropriate to the workload.
Demonstrated customer service skills appropriate to the job.
Access to transportation to off‑site clinical locations.
Excellent written and verbal communication skills in English.
Proven ability to research, evaluate information, and prepare clear, concise, and well‑organized reports, summaries, and correspondence.
Proven organizational skills and attention to detail; ability to multi‑task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, and achieve high productivity/quality within short time frames; skill in working independently and as part of a team.
Proven ability to analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly.
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.
Proven ability to establish and maintain files and records.
Working knowledge of computer software, including Microsoft Office.
Proven ability to establish and maintain cooperative and collegial working relationships; skill in interacting with the public, faculty and staff of diverse backgrounds.
High school graduation and sufficient experience to successfully perform the assigned duties and responsibilities.
A minimum of 1 year of related work experience as a Clinical Research Coordinator (CRC) or Assistant CRC with a Bachelor’s degree or equivalent experience.
Demonstrated track record of human subjects research (Phase I–III drug trials, device trials), informed consent procedures, 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 (National Group, Industrial, Investigator‑authored).
Preferred: SOCRA or ACRP Certification.
Special Conditions
May require study management coordination outside normal business hours.
Requires travel to off‑site research locations.
Benefits & Compensation Total Rewards: We offer a wealth of benefits to make working at UCI even more rewarding, including medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks.
Conditions of Employment Applicants must comply with a background check, live‑scan employment, legal right to work in the United States, vaccination policies, smoking and tobacco policy, drug‑free environment, misconduct disclosure requirement, California Child Abuse and Neglect Reporting Act, E‑Verify, and pre‑placement health evaluation. (Additional details can be found at https://hr.uci.edu/new-hire/conditions-of-employment.php)
Equal Opportunity Employment 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.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824‑0500 or eec@uci.edu.
Work Authorization Sponsorship Must be able to provide proof of work authorization.
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The University of California, Irvine (UCI) is a top research university founded in 1965, affiliated with the prestigious Association of American Universities and 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, UCI has more than 36,000 students and offers 224 degree programs. It is 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.
Seniority level:
Entry level
Employment type:
Full-time
Job function:
Research, Analyst, and Information Technology
Responsibilities
Coordinating clinical trials in the Department of Orthopaedic Surgery.
Comprehensive coordination and data management of complex Phase I–IV clinical research protocols from initiation through completion of research projects with human subjects.
Conducting interviews with study patients in the clinic, screening participants, and collecting data in compliance with established study protocols.
Developing and establishing processes for review and oversight of clinical trials conducted by investigators, ensuring study protocols are followed, appropriate documentation is kept, and accurate data is collected according to Good Clinical Practice (GCP), internal SOPs, and University policies.
Completing timely and accurate data collection and coordination of data submission to study sponsors, ensuring quality control and leading to timely milestone payments.
Compiling and transcribing research patient data and study‑related information into case report forms (CRFs) and sponsor‑specific electronic data capture systems (EDC).
Assisting Principal Investigators and study coordinators with all data management aspects of non‑cancer related trials.
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.
Accurately maintaining clinical trial information in the clinical trial management system (OnCore) and adhering to institutional policies.
Working at both main locations in Orange and Irvine, and sometimes at community sites depending on responsibilities and scheduling demands.
Qualifications
Ability to establish and maintain effective working relationships across the Health System.
Ability to maintain a work pace appropriate to the workload.
Demonstrated customer service skills appropriate to the job.
Access to transportation to off‑site clinical locations.
Excellent written and verbal communication skills in English.
Proven ability to research, evaluate information, and prepare clear, concise, and well‑organized reports, summaries, and correspondence.
Proven organizational skills and attention to detail; ability to multi‑task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, and achieve high productivity/quality within short time frames; skill in working independently and as part of a team.
Proven ability to analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly.
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.
Proven ability to establish and maintain files and records.
Working knowledge of computer software, including Microsoft Office.
Proven ability to establish and maintain cooperative and collegial working relationships; skill in interacting with the public, faculty and staff of diverse backgrounds.
High school graduation and sufficient experience to successfully perform the assigned duties and responsibilities.
A minimum of 1 year of related work experience as a Clinical Research Coordinator (CRC) or Assistant CRC with a Bachelor’s degree or equivalent experience.
Demonstrated track record of human subjects research (Phase I–III drug trials, device trials), informed consent procedures, 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 (National Group, Industrial, Investigator‑authored).
Preferred: SOCRA or ACRP Certification.
Special Conditions
May require study management coordination outside normal business hours.
Requires travel to off‑site research locations.
Benefits & Compensation Total Rewards: We offer a wealth of benefits to make working at UCI even more rewarding, including medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks.
Conditions of Employment Applicants must comply with a background check, live‑scan employment, legal right to work in the United States, vaccination policies, smoking and tobacco policy, drug‑free environment, misconduct disclosure requirement, California Child Abuse and Neglect Reporting Act, E‑Verify, and pre‑placement health evaluation. (Additional details can be found at https://hr.uci.edu/new-hire/conditions-of-employment.php)
Equal Opportunity Employment 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.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824‑0500 or eec@uci.edu.
Work Authorization Sponsorship Must be able to provide proof of work authorization.
#J-18808-Ljbffr