Assistant Regulatory Affairs Coordinator

Overview

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.

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…