Clinical Research Regulatory Specialist III

Regulatory Specialist III

Job Type: Open-Ended Contract

Must reside in one of the following states:

Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia,

Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota,

Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio,

Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia

Key Responsibilities

• Support IND/IDE and biologics submissions, including FDA reporting activities
• Coordinate with IRBs, FDA, investigators, sponsors, and CROs
• Oversee multi-site clinical trials, ensuring adherence to regulatory timelines and accuracy
• Prepare and submit:
  • New study protocols, amendments, and continuing reviews
  • Informed consent forms and updates
  • Regulatory reports and essential documentation
• Ensure compliance with ICH/GCP guidelines, FDA regulations, and AAHRPP standards
• Maintain audit-ready documentation within eRegulatory systems

Required Qualifications

• Bachelor’s degree (or equivalent experience)
• Minimum of 3 years of Regulatory experience in clinical research  
• Minimum of 2 years of Oncology clinical research experience
• MUST have Sponsor-initiated clinical trial experience
• Hands-on expertise with:
  • Regulatory submissions and compliance processes
  • Study start-up, maintenance, and close-out
  • Quality assurance and regulatory documentation
• Strong ability to manage multiple studies and collaborate across stakeholders

Active certification required from a recognized organization:

• SOCRA (CCRP)
• ACRP (CCRC)

This is a Contract to Hire position based out of Orlando, FL.

The pay range for this position is $36.00 - $40.00/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)

This is a fully remote position.

This position is anticipated to close on Jul 3, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $36 - $40