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 Alpha Stem Cell Clinic (ASCC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance stem cell clinical research and activities at UCI. The UCLA-UCI Alpha Stem Cell Clinic:

* Is part of the California Institute for Regenerative Medicine (CIRM) Alpha Stem Cell Clinic network
* Promotes and facilitates scientific collaborations and interactions
* Provides centralized clinical research infrastructure support
* Accelerates the implementation of clinical research trials

Under the general direction of the Assistant Director of Clinical Research Operations, the Assistant Regulatory Affairs Coordinator (ARAC) will work directly with the lead Regulatory Affairs Coordinator to ensure successful management of the regulatory aspects of each study. Responsibilities include preparation and/or collection of study related regulatory documents required by IRB, FDA, study sponsor, CRO and Principal Investigator. Ensure all regulatory aspects of studies are up-to-date through OnCore. Maintain study regulatory binder by working closely with CRO and study staff to ensure all documents are filed appropriately and up to date. Organizes and oversees various study-related meetings with both study sponsors and internal staff. Works with each attendees' calendars to schedule meetings, send invites, takes meeting notes, and completes follow-up action items. Provides back-up assistance when lead regulatory coordinator is out of office and ensures study proceeds without delay. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Assists with various regulatory-related projects within the team and department. Participates in trainings required by both UCI and other governing bodies such as HIPAA, GCP, and various compliance trainings.

Required:

• Excellent communication skills: Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
• 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
• Willingness to work as a supportive, cooperative member of an interdisciplinary team
• Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly
• Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence
• Demonstrated ability to organize and prioritize a complex and dynamic workload
• Ability to multitask and meet deadlines, despite interruptions
• Ability to independently exercise discretion and sound judgment
• Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships
• Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds
• 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
• Skill in working independently, taking initiative and following through on assignments
• Ability to think critically, compiles data from various sources, analyze data, and prepare reports.
• Ability to work both independently and as part of team
• Ability to analyze problems, implement solutions and multitask
• Ability to work within a deadline-driven structure
• High level of integrity and honesty in maintaining confidentiality
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Bachelor's degree and 1-3 years of experience or equivalent experience.

Preferred:

• Ability to take initiative and demonstrate strong commitment to duties
• Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change
• Foster and promote a positive attitude and professional appearance

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.

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.