Research Regulatory Specialist III

Job Description

The Research Regulatory Specialist III provides regulatory support to the research team by conducting all the tasks and activities of the Research Regulatory Specialist I, and has the additional responsibilities of assisting the Research Regulatory Specialist III to support research investigators with investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA. The role also includes coordination of regulatory activities for multi-site research protocols. The Specialist functions as a liaison between the IRB of record for each study protocol, the FDA, the investigator, the study team, other study teams participating in multi-site studies, the Sponsor, Contract Research Organization (CRO), Office of Sponsored Programs (OSP), the research Conflicts of Interest (COI) office, the clinical research department Managers and Sr. Managers, and Leadership.

ResponsibilitiesAssist with the submission of research protocols and other required documents/components to the FDA for investigational new drug (IND)/investigational device exemption (IDE) or biologics applications.Provide data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.Assist with technical review and report preparation and submission of FDA required reports for ongoing sponsored and held IND/IDE applications.Coordinate regulatory processes and submissions for multi-site research.Assist the Research Regulatory Manager in the orientation of new Research Regulatory Specialists.Prepare and submit new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates, and ensure the completeness and accuracy of documents while meeting submission deadlines.Prepare and submit new informed consent documents, revisions to the informed consent, and communicate when IRB requires re-consenting of enrolled subjects. Ensure all languages of the informed consent requested by the study team are reviewed and approved.Ensure all regulatory documents, including Essential Documents as defined by ICH/GCP guidelines, are in compliance with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and all applicable policies and procedures.Monitor all required review, approval, and clearance activities for each research protocol, maintaining detailed, complete, accurate, and current records.Maintain regulatory documents by creating electronic folders in the eRegulatory application, filing them electronically, following standard file name criteria, and keeping all documents current per SOP and Federal, State, and IRB requirements.Essential SkillsClinical researchOncologyQuality assuranceRegulatory documentsRegulatory complianceRegulatory submissionStart-up, maintenance, and close-out of studiesAdditional Skills & QualificationsBachelor’s degree in healthcare related field or biological sciences and at least 3 years of work experience in a Regulatory research role. Documented experience in submitting and maintaining regulatory documents including research essential regulatory documents, conflicts of interest, and financial conflicts of interestMUST HOLD active certification through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&RWork Environment

Remote

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

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

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