Assistant Regulatory Affairs Coordinator

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.

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.

You must be able to commute to the Orange and Irvine location. This position is onsite.

Required:

• Ability 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 demands
• Maintains 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.
• Excellent problem-solving skills and quick-thinker capabilities
• Proficient in Microsoft Office to be able to generate reports and documents in Word, Excel and PPT
• Basic understanding of clinical trials/research
• Strong communication skills as this role requires constant contact with all study stake holders including study sponsors, CROs, PIs, and various units within the department
• Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.

Preferred:

• CCRP preferred, but not required
• Clinical research experience preferred, but not required

Special Conditions:

• Willing to take certification course after 1-2 years of on-the-job training
• Must be willing to and able to commute to two different office locations: Irvine and Orange

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.

The expected pay range for this recruitment is $26.6- $43.82 (Hourly).

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 - https://hr.uci.edu/new-hire/conditions-of-employment.php

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 (949) 824-0500 or eec@uci.edu.