Actively looking to hire a remote Oncology Research Regulatory Specialist III! Must be SOCRA or ACRP certified! Can sit anywhere in the US but support EST hours! Monday to Friday; no weekends or holidays!

Responsibilities

• Assist 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 Skills

• 4 years regulatory experience
• Oncology experience
• Quality assurance
• Regulatory documents
• Regulatory compliance
• Regulatory submission
• Start-up, maintenance, and close-out of studies

Additional Skills & Qualifications

• Bachelor’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 interest
• MUST HOLD active certification through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&R

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

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.

Salary : $28 - $38