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University of California Irvine Health

Regulatory Affairs Coordinator

University of California Irvine Health, Orange, California, United States, 92613


Regulatory Affairs Coordinator

Req ID:

93326

Location:

Irvine, California

Division:

School of Medicine

Department:

UCI Ctr for Clinical Research

Position Type:

Full Time

Salary Range Minimum:

USD $33.08/Hr.

Salary Range Maximum:

USD $54.51/Hr.

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.

The UCI Center for Clinical Research (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.

Your Role on the Team

Under the supervision of the Clinical Research Manager and the Director of Clinical Research Operations, the incumbent is responsible for coordinating clinical trials in the UCI Center for Clinical Research (CCR). The incumbent is responsible for all aspects of clinical research from initiation through completion of research projects with human subjects. Responsibilities include conducting interviews with study patients, screening participants, and collecting data in compliance with established study protocols. The incumbent will develop and establish processes for review and oversight of clinical trials conducted by investigators, ensuring study protocols are followed, appropriate documentation is kept, and accurate data is collected. The CCR offices and clinics are located at the UCI Medical Center in Orange and the UCI campus in Irvine, and the incumbent will be required to work at both locations depending on responsibilities and scheduling demands.

What It Takes to be Successful

Required:

Demonstrated track record of human subjects research (Phase I, II, III drug trials, and device trials) coordination, informed consent procedures and documents, and IRB submissions. Experience working in a medical/clinical setting and familiarity with medical terminology. Ability to establish and maintain effective working relationships with all levels of campus and hospital administration staff, faculty, and industry sponsors.

Ability to work after-hours and occasional weekends.

Excellent organizational skills, ability to prioritize, handle multiple tasks concurrently, and function under time constraints. Demonstrated evidence of successful multi-tasking and complex problem-solving abilities.

Proficient in MS Word, Excel and PowerPoint. Good communication skills both oral and written. Ability to independently compose correspondence using proper English grammar and spelling.

Preferred:

Knowledge of University IRB policies and procedures as they apply to the submission and conduct of clinical research.

Familiarity with University contract and grant procedures in the conduct of clinical trials.

Knowledge of OnCore, Epic, EDC Systems (iMedidata, Medrio, Datatrack), IWRS systems, Kuali Systems.

Experience working with IRB, IACUC, and ICTS.

Previous UC system experience.

Knowledge of basic accounting and familiarity with UCI fund accounting and disbursement procedures.

Special Conditions:

Some after business hours and occasional weekends.

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.

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. 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.

To apply, visit

https://jobs.uci.edu/careers-home/jobs/93326

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