Coordinator, Operations Support (IRB)

Responsible for creating, submitting, and closing out studies that are submitted to Institutional Review Board (IRB) submissions for human subject research in cosmetics testing, while also driving AI-enabled process improvements across regulatory and operational workflows. This role blends regulatory expertise with innovation, ensuring studies are compliant and efficient.

JOB FUNCTIONS

Assists in the development of study documents and study preparation for IRB studies

Reviews and submits study protocols, informed consent forms, protocol deviations and adverse event reports, and supporting documentation to IRBs

Tracks submission status, approvals, amendments, renewals, and closures

Maintains accurate regulatory documentation and audit-ready files

Engages with clients (when applicable) during study preparation phase to ensure all necessary documents (safety letter, informed consent, etc.) are finalized prior to IRB submission.

Assists with the development and updating of SOPs, WI, and training material related to study paperwork creation and IRB management.

Ensures compliance with regulations.

Identifies opportunities to apply AI (eg, automation tools) to streamline submission workflows

Monitors performance metrics and continuously optimize processes

Provides excellent customer service to clients, and maintains positive interaction with peers and supervisors

Adheres to internal standards, policies, and procedures.

Performs other duties as assigned.

Bachelor’s Degree, preferable in science or equivalent

Minimum 1 year of experience in CRC position with SGS or equivalent clinical research organization, and/or prior project management experience.

Excellent organizational and documentation skills.

Proficiency with Microsoft Office applications, including Outlook, Word and Excel.

Previous IRB experience and / or clinical research regulatory experience.

Hands-on experience with AI tools for process automation, agent creation, and document creation.

CCRC or CCRA Certification preferred

Language Skills: Native-level English

Mathematical and Reasoning Skills: Intermediate

Work requires willingness to work a flexible schedule

Longer hours, evenings and/or weekend work will be necessary occasionally as job duties demand

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

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