Regulatory Coordinator

Overview

Manage regulatory docs, IRB submissions, audits for 150 clinical studies.

Key Responsibilities

• regulatory compliance
• audit coordination
• document management
• study monitoring
• pi liaison
• irb submissions

Tasks

-Support regulatory compliance for approximately 150 ongoing studies at a small, fast-paced clinical site. -Coordinate and assist with internal and external audits, ensuring readiness and proper documentation. -Take advantage of opportunities to learn across multiple aspects of clinical research and regulatory processes. -Serve as the go-to person for routine regulatory tasks, including document preparation, updates, and compliance checks. -Monitor adherence to regulatory requirements and site-specific policies throughout the lifecycle of each study. -Act as a liaison between the PI and regulatory bodies, providing updates and clarifications as needed. -Perform catch-up work on backlogged studies to bring documentation and submissions up to date. -Maintain accurate paper-based regulatory files for all clinical studies, ensuring compliance with applicable guidelines and site SOPs. -Prepare and submit Institutional Review Board (IRB) applications, amendments, and continuing reviews in a timely manner.

Requirements

• regulatory
• irb
• audits
• onsite
• paper docs
• 2+ yrs

What You Bring

-2+ years of Regulatory experience -Experience with IRB submissions -Experience with audits -Ability to work onsite in Fountain Valley, CA -Comfortable with paper documentation

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Benefits

-Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Health Spending Account (HSA) -Regulatory Coordinator Job Opportunity with Dermatology Clinic*** -Transportation benefits -Critical Illness, Accident, and Hospital -Medical, dental & vision -Time Off/Leave (PTO, Vacation or Sick Leave) -Short and long-term disability -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms