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UC Irvine · 1 day ago

Assistant Regulatory Affairs Coordinator

Orange County, CA

Full-time

Onsite

Entry Level

1+ years exp

UC Irvine is a prestigious public university known for its academic achievement and research. The Assistant Regulatory Affairs Coordinator will assist in managing the regulatory aspects of clinical studies, ensuring compliance with IRB, FDA, and sponsor requirements while maintaining study documentation and facilitating meetings.

Higher Education

Diversity & Inclusion

No H1B

Responsibilities

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

Qualification

Regulatory document preparationClinical research knowledgeMicrosoft ExcelHIPAA complianceCommunicationOrganizational skillsProblem solvingTeam collaboration

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