University of California - Irvine
Regulatory Affairs Coordinator- HYBRID
University of California - Irvine, Orange, California, United States, 92613
Who We Are
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 www.uci.edu.The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients.
Your Role on the Team
Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
Responsibilities include:Independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other ancillary committees.Effectively shepherding protocols through the regulatory committee process to ensure activation of trials.Serving as the liaison to sponsors and governing agencies.Maintaining communication with all elements of a multi-level research network.Accurately maintaining regulatory information in the clinical trial management system (OnCore).What It Takes to be Successful3 to 5 years of related work coordination experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.Experience with cancer-related research.Strong attention to detail and communication skills.Ability to work both independently and as part of a team.Experience with submitting to various institutional research committees.Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).Ability to multitask and meet deadlines.
Special Conditions:May require study management coordination outside of normal business hours.May require travel to satellite sites.Total CompensationIn addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding.Conditions of Employment:Background Check and Live ScanLegal Right to work in the United StatesVaccination PoliciesSmoking and Tobacco PolicyDrug Free EnvironmentThe University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.Consideration for Work Authorization SponsorshipMust be able to provide proof of work authorization
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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 www.uci.edu.The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients.
Your Role on the Team
Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
Responsibilities include:Independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other ancillary committees.Effectively shepherding protocols through the regulatory committee process to ensure activation of trials.Serving as the liaison to sponsors and governing agencies.Maintaining communication with all elements of a multi-level research network.Accurately maintaining regulatory information in the clinical trial management system (OnCore).What It Takes to be Successful3 to 5 years of related work coordination experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.Experience with cancer-related research.Strong attention to detail and communication skills.Ability to work both independently and as part of a team.Experience with submitting to various institutional research committees.Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).Ability to multitask and meet deadlines.
Special Conditions:May require study management coordination outside of normal business hours.May require travel to satellite sites.Total CompensationIn addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding.Conditions of Employment:Background Check and Live ScanLegal Right to work in the United StatesVaccination PoliciesSmoking and Tobacco PolicyDrug Free EnvironmentThe University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.Consideration for Work Authorization SponsorshipMust be able to provide proof of work authorization
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