Assistant Regulatory Affairs Coordinator

University of California, Irvine • Orange, CA

2d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees