• Regulatory Affairs Specialist

    Actalent (Charleston, SC)


    Job Title: Regulatory Affairs Specialist (Internal Auditing Focused)

    Job Description

    We are seeking a dedicated and experienced research professional to join our team in a role that involves conducting audits of national cooperative group trials, ensuring compliance with high-risk protocols and potential FDA registration trials. This position is integral to maintaining protocol compliance and enhancing operational efficiency within our organization.

    Responsibilities

    + Conduct internal audits of national cooperative group trials, Phase II studies, and high-risk protocols to ensure protocol compliance.

    + Perform new employee enrollment audits focusing on GCP, IRB SOPs, and best practices.

    + Prepare and submit audit reports using standard templates and document findings in the clinical trials management system (CTMS).

    + Maintain expert knowledge of FDA, GCP, ICH, IRB, and institutional regulations.

    + Collaborate with the QAE Program Manager to onboard and train CTO staff on SOPs, IRB policies, GLPs, GCPs, and ICH guidelines.

    + Verify source documentation for selected CRF fields and confirm subject eligibility.

    + Track audits, sponsor monitor letters, and performance reports using OnCore CTMS, CTO Clinical Data Center, and NCI RAVE metrics.

    Required Skills & Experience

    + 2+ years’ experience as an within internal auditing/regulatory affairs for clinical trials.

    + Bachelors Degree or higher required.

    + Oncology experience highly preferred.

    + Expert knowledge of FDA, GCP, ICH, IRB, and institutional regulations.

    Pay and Benefits

    The pay range for this position is $33.65 - $36.06/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

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

     

    Workplace Type

     

    This is a fully onsite position in Charleston,SC.

     

    Application Deadline

     

    This position is anticipated to close on Nov 7, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.