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Updated: Apr 18, 2024
Location: Orange-Campus
Job Type:
Department: UCI Ctr for Clinical Research
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.
Department Website:
Home | Center for Clinical Research | UCI
Required:
- 1-3 years as a Regulatory Affairs Coordinator or the equivalent education or experience
- Associates or Bachelor's Degree. Or the equivalent experience.
- Ability to establish and maintain effective working relationships across the Health System.
- Ability to maintain a work pace appropriate to the workload.
- Must demonstrate customer service skills appropriate to the job.
- Excellent written and verbal communication skills in English.
- Must possess the skill, knowledge and ability essential to the successful performance of assigned duties.
- 3-5 years of experience with regulatory aspects of clinical research including maintaining regulatory documents, submitting IRB application, and working with study sponsors and monitors.
- Basic knowledge of Microsoft Word, Excel, PowerPoint. Demonstrated problem solving capabilities.
- Excellent interpersonal communication skills, both oral and written.
- Ability to work under minimal supervision and know how to escalate to proper authorities when needed.
- Ability to comprehend complex documents such as study protocols, guidance documents, and study manuals then synthesize information.
- Ability to prioritize tasks when different stakeholders involved and with competing priorities and deadlines.
- Ability to work well with teams both within and outside of department.
- Ability to work well with teams both within and outside of department.
- Ability to travel to both medical center in Orange or to main office site in Irvine.
- Experience with IND submission.
- CCRP
- Experience as a clinical research coordinator and/or familiar with the clinical side (versus the regulatory side) of a study.
- Experience with CTMS, preferably OnCore.
- CCRP Certified through one of the national clinical research associations (SOCRA or ACRP) or willing to become certified.
- Familiar with FDA Inspection process.
- Ability to travel to either Orange Medical Center or main office in Irvine
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
- Legal Right to work in the United States
- Vaccination Policies
- Smoking and Tobacco Policy
- Drug Free Environment
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, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination 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 [emailprotected]
University of California, Irvine Office of Equal Opportunity and Diversity (OEOD) (949) 824-5594 oeod@uci.edu