• New York, NY
• Research
• 3029754
• 08/07/2025
  Description
  The Regulatory Assistant II plays a vital role in supporting clinical research compliance by managing and maintaining electronic regulatory binders. This position ensures that all regulatory documentation is accurate, current, and audit-ready, while collaborating closely with regulatory affairs teams to uphold institutional and federal standards.
  Maintaining regulatory compliance in clinical trials is essential for safeguarding patient safety, upholding ethical standards, ensuring data integrity, and facilitating the development and approval of new medical treatments and technologies. This position offers an opportunity to play a critical role in ensuring regulatory compliance and document management within a dynamic and fast-paced environment. The successful candidate will have the chance to work closely with regulatory affairs professionals and gain valuable experience in the pharmaceutical or healthcare
  Responsibilities

Qualifications

• Associates Degree in related field or HS Diploma with equivalent related experience
• Bachelor’s degree preferred
• 1 year of research experience; preferably in a multi-site trial setting
• Creative problem solving skills; ability to navigate through ambiguous situations
• Strong organizational, communication and interpersonal skills
• Ability to manage competing priorities and deadlines in a fast paced environment
• Proficiency with MS 365 office suit

• Participate in required teleconferences, on-site meetings as required.
• Performs all other related duties as assigned.
• Prepare for study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.
• Maintain working knowledge of current regulations, regulatory guidance and or local policies.

Qualifications

• Associates Degree in related field or HS Diploma with equivalent related experience
• Bachelor’s degree preferred
• 1 year of research experience; preferably in a multi-site trial setting
• Creative problem solving skills; ability to navigate through ambiguous situations
• Strong organizational, communication and interpersonal skills
• Ability to manage competing priorities and deadlines in a fast paced environment
• Proficiency with MS 365 office suite

Employer Description