Regulatory Specialist III

Actively looking to hire multiple remote Regulatory Specialist level III to join a growing research site! This is a Monday to Friday; no weekends or holidays! Must be SOCRA or ACRP certified to qualify for this position.

Duties;

• Functions as a liaison between the IRB of record for each study protocol, the Food and Drug Administration (FDA), and the investigator, the study team, other study teams participating in led 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.
• Responsible for assisting with the submission of research protocols and other required documents/components to the FDA for held investigational new drug (IND)/investigational device exemption (IDE) or biologics applications.
• Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
• Assists with the technical review and report preparation and submission of FDA required reports of ongoing sponsored and held IND/IDE applications.
• Coordinates regulatory processes and submissions for multi-site research.
• Assists Research Regulatory Manager in the orientation of new Research Regulatory Specialists.
• Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates (investigational brochures and/or device manuals) and ensuring completeness and accuracy of documents while meeting all applicable submission deadlines.
• Responsible for preparing and submitting new informed consent documents, revisions to the informed consent, including any required financial disclosure language, and communicating when IRB requires re-consenting of enrolled subjects. Also ensuring all languages of the informed consent requested by the study team are reviewed and approved.
• Ensure all regulatory documents, including all Essential Documents as defined by the ICH/GCP guidelines, are in compliance with all applicable Federal regulations, ICH/GCP guidelines, as well as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and all applicable policies and procedures
• Maintains regulatory documents by creating electronic folders in the eRegulatory application, filing them electronically, following standard file name criteria and keeping all documents current

Qualifications:

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelor’s degree in healthcare related field or biological sciences and at least 2 years work experience in a clinical research setting; OR
• Associate Degree and at least 3 years work experience in a healthcare or scientific setting, with at least 2 years in a clinical research setting; OR
• Equivalent work consisting of at least five (5) years of experience working in a healthcare or scientific setting, with at least 2 years in a clinical research setting including an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company. Work experience includes documented experience in submitting and maintaining regulatory documents including research essential regulatory documents, conflicts of interest, financial conflicts of interest, and/or ClinicalTrials.gov.

LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:

• Certification through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R)

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

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

Salary : $28 - $38