Job Title: Regulatory SpecialistJob DescriptionThe Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP), and Institutional policies. The Regulatory Specialist will serve as a liaison to investigators, collaborating divisions, departments, and institutions, the Institutional Review Board (IRB), and external regulatory agencies.Essential Job Functions:
Organize and maintain the regulatory binder; file essential documents, obtain signatures for delegation logs, training logs, and other essential study documents.
Review sponsor templates and site-level Informed Consent Forms (ICF) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
Participate in the regulatory review, preparation, and submission of clinical study documentation (e.g., investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug (IND), treatment and compassionate/emergent use) as required.
Ensure timely and accurate submission of all protocol amendments, ICF, Investigator Brochure, and other administrative items to the IRB of record.
Arrange for receipt and/or transmission of administrative and regulatory documents and file Serious Adverse Event (SAE) and IND safety reports.
Review and interpret IRB correspondence with the research team and notify the team of all determinations that may affect the safety and welfare of human subjects.
Obtain and maintain updated lab/test ranges.
Update electronic databases for any personnel changes.
Act as a liaison between investigators, sponsors, their representatives, and the IRB on all regulatory issues.
Assist investigators in obtaining necessary access to facilitate research readiness.
Provide timely follow-up, issue resolution, update reports, and problem escalation as necessary.
Attend and actively participate in study team meetings, sponsor meetings, research meetings, and conferences/in-service education sessions as required.
Prepare the regulatory binder for monitor visits, audits, or site inspections.
Perform other work-related duties as assigned.
Assist with orienting new staff on their regulatory responsibilities.
Serve as a resource for questions related to regulations affecting clinical research.
Stay abreast of developments in GCP and federal regulations regarding clinical research.
Maintain overall awareness in the field of clinical research, as well as assigned areas, by reading related literature, attending training classes, attending professional meetings, etc.
Assist in developing procedures to ensure regulatory compliance.
Hard Skills
Clinical trial regulatory experience
Dealing with IRB
Maintaining components of clinical trials
GCP compliance
ICH guidelines
Regulatory documentation preparation and submission
Soft Skills
Attention to detail
Communication
Problem-solving
Team collaboration
Adaptability
Time management
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Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.