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Coordinator, Operations Support; IRB

Job in Richardson, Dallas County, Texas, 75080, USA
Listing for: PVH (Tommy Hilfiger/Calvin Klein)
Full Time position
Listed on 2026-07-13
Job specializations:
  • Research/Development
    Regulatory Compliance Specialist, Clinical Research
Salary/Wage Range or Industry Benchmark: 70000 - 100000 USD Yearly USD 70000.00 100000.00 YEAR
Job Description & How to Apply Below
Position: 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 (e.g., 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.
Qualifications and Requirements
  • 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  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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