Regulatory Specialist I

Job Description

The Regulatory Specialist I provides vital regulatory support to the research team by managing all Institutional Review Board (IRB) and regulatory submissions and maintenance for research activities. This role involves coordinating the research protocol from start-up to close-out phases, ensuring compliance with Federal regulations, institutional policies, and other requirements. The Specialist functions as a liaison between various stakeholders, including the IRB, investigators, study team, sponsors, Contract Research Organizations (CRO), Office of Sponsored Programs (OSP), and leadership.

Responsibilities

• Prepare and submit new research protocols, protocol amendments, continuing reviews, and investigational product updates ensuring document accuracy and meeting submission deadlines.
• Prepare and submit informed consent documents and revisions, ensuring all languages requested by the study team are reviewed and approved.
• Ensure all regulatory documents comply with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and institutional policies.
• Monitor review, approval, and clearance activities for research protocols, maintaining detailed and accurate records.
• Maintain regulatory documents by creating and managing electronic folders in the eRegulatory application, following standard criteria.
• Assist in coordinating sponsor monitoring visits and ensure proper access to eRegulatory files.
• Disseminate regulatory communications and study updates to relevant parties to ensure protocol adherence and compliance.
• Provide timely follow-up on requests from IRB, sponsors, and study teams in a professional manner.
• Archive and maintain regulatory documents for closed studies per regulatory retention requirements.
• Facilitate research credentialing for all staff and maintain accurate research personnel logs and documentation.
• Communicate with the COI office and notify the study team of any COI Management Plans.
• Confirm and ensure research protocols are registered on ClinicalTrials.gov when required.
• Support auditing and monitoring needs by assisting auditors and providing necessary documents.
• Perform other duties or special projects as assigned by the Research Regulatory Manager or Director.

Essential Skills

• Clinical research
• Regulatory knowledge
• IRB regulatory submission
• Regulatory compliance
• FDA regulations
• Oncology and clinical trial experience

Additional Skills & Qualifications

• Associate degree in healthcare or biological science related field
• Minimum two years of experience in healthcare, clinical research, or a scientific setting, or related field

Work Environment

The position is based in an office setting, focusing on electronic document management and regulatory compliance tasks.

Pay and Benefits

The pay range for this position is $26.00 - $30.00/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)

Workplace Type

This is a fully onsite position in Orlando,FL.

Application Deadline

This position is anticipated to close on May 15, 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $26 - $30