Regulatory and Quality Assurance Associate

PEGUS Research is looking for a detail-oriented and motivated self-starter to join our Regulatory Affairs and Quality Assurance (RAQA) team. Our research broadens consumer healthcare choices and has a positive impact on public health. Joining our team lets you contribute to this unique mission. This is also a great opportunity for an early career professional to gain research experience and expand their skills.

The PEGUS Research RAQA team reviews and submits key study documents to ethics boards, ensures studies are conducted in compliance with FDA regulations, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements and standards including ethical conduct.

The RAQA Associate I directly contributes to the team in these ways:

• Reviews, files, and organizes essential study documentation in the Trial Master File.
• Ensures documentation follows FDA and other regulations
• Assists in the work of identifying, addressing, and eliminating causes of non-compliance
• Assists in preparing studies for audits
• Assists in the annual review of company Standard Operating Procedures
• Prepares documents for submission to the IRB (ethics review board)
• Prepare study documents for archiving and storage

• Associates degree required; bachelor's degree preferred
• Strong written and verbal communication skills, with a can-do attitude
• Knowledge of computer systems for document creation and collaboration, especially MS Office and Adobe Acrobat.
• Organized, detail oriented, and ability to learn quickly with a desire to improve and enhance processes
• Strong work ethic, with the ability to take initiative and work independently as needed
• Attention to detail, and good interpersonal skills
• Knowledge of Good Documentation Practices, a plus.

• Starting Pay: $17.50 - $20.00 hourly (based on education, experience and fit)
• Approximately 40 hours per week, during regular business hours (M-F, 9-5)
• Medical, dental, vision, life and disability insurance, up to 4% match on our 401(k) plan and HSA contribution
• 13 paid holidays and paid time off equivalent to 13 days per year
• Mostly flexible work environment with the ability to work from your home, as assigned
• Growth potential and skill building opportunities
• A great team environment: we work hard and have fun doing it!