University Of California Irvine
Assistant Regulatory Affairs Coordinator
University Of California Irvine, Irvine, California, United States, 92713
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 UCI Center for Clinical Research was built on the belief that running clinical trials should be a seamless experience. We work across the UCI enterprise to offer patients, investigators, and industry partners the quick and effortless support they need to participate in and run successful clinical trials. Our goals are to:
Innovate - capitalized on opportunities by developing fresh ideas and innovative approaches to improving our daily work.
Accelerate - Work as a team of teams, driving process simplification, and standardization to surpass our study activation and enrollment targets.
Grow & Inspire - Set the industry bar for world-class experiences for each other, our patients and partners, and elevate our brand as high performers.
For more information on CCR, please visit our website at https://clinicalresearch.som.uci.edu.Your Role on the Team
The Assistant Regulatory Affairs Coordinator position will work directly with the Lead Regulatory Coordinator to ensure successful management of the regulatory aspects of each study conducted through UCI's Center for Clinical Research. This position will work a hybrid, onsite/from home, schedule and report on site to both Irvine and Orange offices as directed.What It Takes to be Successful
Required:Must be willing to and able to commute to two different office locations: Irvine and OrangeStrong communication skills as this role requires constant contact with all study stake holders including study sponsors, CROs, PIs, and various units within the departmentExcellent problem-solving skills and quick-thinker capabilitiesAbility 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 demandsMaintains high level of professionalism as this role requires staff to be the "face" of the study to various stakeholders including industry study sponsors, CROs, PIs, and other study collaborators. Failure to do so would result in affecting relationships and reputation of the unit and affect future collaborations.Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible schedulingBasic understanding of clinical trials/researchWilling to take certification course after 1-2 years of on-the-job trainingAble to travel to different office locations and or study sitesProficient in Microsoft Office to be able to generate reports and documents in Word, Excel and PPTClinical research experience preferred, but not required
Preferred:CCRP preferred, but not required
Special Conditions:Ability to work both from home and on site at both offices in Irvine and OrangeTotal CompensationIn 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 ScanLegal Right to work in the United StatesVaccination PoliciesSmoking and Tobacco PolicyDrug Free EnvironmentThe following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.California Child Abuse and Neglect Reporting ActE-VerifyPre-Placement Health EvaluationDetails of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php
Closing Statement:The 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.
For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20.
For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination.
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 (949) 824-0500 or eec@uci.edu.Consideration for Work Authorization Sponsorship
Must be able to provide proof of work authorization
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 UCI Center for Clinical Research was built on the belief that running clinical trials should be a seamless experience. We work across the UCI enterprise to offer patients, investigators, and industry partners the quick and effortless support they need to participate in and run successful clinical trials. Our goals are to:
Innovate - capitalized on opportunities by developing fresh ideas and innovative approaches to improving our daily work.
Accelerate - Work as a team of teams, driving process simplification, and standardization to surpass our study activation and enrollment targets.
Grow & Inspire - Set the industry bar for world-class experiences for each other, our patients and partners, and elevate our brand as high performers.
For more information on CCR, please visit our website at https://clinicalresearch.som.uci.edu.Your Role on the Team
The Assistant Regulatory Affairs Coordinator position will work directly with the Lead Regulatory Coordinator to ensure successful management of the regulatory aspects of each study conducted through UCI's Center for Clinical Research. This position will work a hybrid, onsite/from home, schedule and report on site to both Irvine and Orange offices as directed.What It Takes to be Successful
Required:Must be willing to and able to commute to two different office locations: Irvine and OrangeStrong communication skills as this role requires constant contact with all study stake holders including study sponsors, CROs, PIs, and various units within the departmentExcellent problem-solving skills and quick-thinker capabilitiesAbility 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 demandsMaintains high level of professionalism as this role requires staff to be the "face" of the study to various stakeholders including industry study sponsors, CROs, PIs, and other study collaborators. Failure to do so would result in affecting relationships and reputation of the unit and affect future collaborations.Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible schedulingBasic understanding of clinical trials/researchWilling to take certification course after 1-2 years of on-the-job trainingAble to travel to different office locations and or study sitesProficient in Microsoft Office to be able to generate reports and documents in Word, Excel and PPTClinical research experience preferred, but not required
Preferred:CCRP preferred, but not required
Special Conditions:Ability to work both from home and on site at both offices in Irvine and OrangeTotal CompensationIn 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 ScanLegal Right to work in the United StatesVaccination PoliciesSmoking and Tobacco PolicyDrug Free EnvironmentThe following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.California Child Abuse and Neglect Reporting ActE-VerifyPre-Placement Health EvaluationDetails of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php
Closing Statement:The 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.
For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20.
For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination.
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 (949) 824-0500 or eec@uci.edu.Consideration for Work Authorization Sponsorship
Must be able to provide proof of work authorization