Assistant Regulatory Affairs Coordinator

2 weeks ago

Orange, California, United States UCI Health Full time
Job Opening ID: 69843

Reports To:
Director - Clinical Research Operations

Working Title:
Assistant Regulatory Affairs Coordinator

Department:
UCI Ctr for Clinical Research

Bargaining Unit:

RX

FLSA:
Non-Exempt

Payroll Job Code:

Job Location:
UCI Campus- Irvine

Percent of Time: 100%

Work Schedule: 8-5, M-F

Employee Class:

CAREER

Position Summary:


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


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.


Total Compensation:


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 $ $43.82 (Hourly Rate). The Full Salary Range for the salary grade this position is assigned to is $ $43.82 (Hourly Rate).


Required:

  • Clinical research experience preferred, but not required
  • Associates or Bachelor's Degree. Or the equivalent experience.
  • CCRP preferred, but not required
  • Must be willing to and able to commute to two different office locations: Irvine and Orange 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 Excellent problem-solving skills and quick-thinker capabilities
  • 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.
  • Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling
  • Basic understanding of clinical trials/research
  • Willing to take certification course after 1-2 years of on-the-job training
  • Able to travel to different office locations and or study sites Proficient in Microsoft Office to be able to generate reports and documents in Word, Excel and PPT
Special Conditions

Required:

  • Ability to work both from home and on site at both offices in Irvine and Orange

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 -

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 or
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