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Temporary Assistant Regulatory Affairs Coordinator

4 months ago

Orange, United States UC Irvine Campus Full time

Updated: Apr 14, 2024
Location: Orange-Campus

**Job Type**:
Department: Temporary Employment Services

**Job Opening ID**:67729

**Reports To**: UCI Temporary Employment Services (TES) Manager

**Working Title**: Temporary Assistant Regulatory Affairs Coordinator

**Department**: UCI Temporary Employment Services (TES) Department

**Bargaining Unit**: RX

**FLSA**: Non-Exempt

**Job Code**: 009336

**Job Location**: UCI Medical Center - Orange

**Percent of Time**: 49%

**Work Schedule**: 8am-5pm, M-F

**Employee Class**: Floater

**Position Summary**:

- This recruitment is for a Temporary Assistant Regulatory Affairs Coordinator position through UC Irvine's internal temporary staffing service.
- Duties include, but are not limited to:

- Provide support and coordination to ensure that study-related procedures, evaluations and follow up requirements are completed on schedule and documented according to the research protocol and GCP standards.
- Function as resource to assist PIs, RNs, CRCs, and other staff to accurately implement protocol parameters and maintain compliance with internal guidelines and GCP.
- Assist in the informed consent process to recruit patients onto clinical studies.
- Assist CRC with initial needs analysis to identify relevant concerns/factors, to support the smooth implementation of study parameters.
- IRB submissions and approval maintenance; maintaining documents/files, maintaining OnCore (Clinical Trials Management System) records.
- Provide support to ensure successful management of the regulatory aspects of each study.

**Compensation Range**:
$26.60/hour (within full range of $26.60 - $27.20/hour)

**Required**:

- Bachelor's degree and 1-3 years of experience or equivalent experience. (Preferred in Science)
- Excellent communication skills.
- Strong and proven organization and administrative skills: scheduling, data/file management, word processing (Microsoft Word), spreadsheets (EXCEL), copying, phone skills, data entry.
- Access to transportation to off-site research locations
- Ability to independently exercise discretion and sound judgment.
- Demonstrated skill in interacting with persons of various social, cultural, economic, and educational backgrounds.

**Preferred**:

- Some experience in regulatory/IRB and/or clinical research.
- Completion of medical/doctoral school.
- Please attach your resume.

**TEMPORARY EMPLOYMENT**
- The majority of our temporary positions are Monday - Friday, 8:00 a.m. - 5:00 p.m. We also have occasional part-time, weekend, and evening hours available, depending on the assignment. Comprehensive benefits options are also available for temporary employees, including paid vacation, holidays, and sick leave.

**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

**PARKING INFORMATION**

**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.
- 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.