Regulatory and Quality Assurance Associate I
About The Position
PEGUS Research is seeking a detail-oriented, motivated self-starter to join its Regulatory Affairs and Quality Assurance (RAQA) team. The role supports research that broadens consumer healthcare choices and contributes to public health, while offering an early-career professional an opportunity to gain research experience and expand their skills. The RAQA team reviews and submits key study documents to ethics boards and helps ensure studies comply with FDA regulations, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements, standards, and ethical practices. The Associate I supports study documentation, compliance activities, audit preparation, Standard Operating Procedure reviews, IRB submissions, and document archiving.
Requirements
- Associate degree required.
- Strong written and verbal communication skills and a can-do attitude.
- Knowledge of computer systems for document creation and collaboration, especially MS Office and Adobe Acrobat.
- Organized and detail-oriented, with the ability to learn quickly and a desire to improve and enhance processes.
- Strong work ethic, with the ability to take initiative and work independently as needed.
- Good interpersonal skills.
Nice To Haves
- Bachelor’s degree preferred.
- Knowledge of Good Documentation Practices.
Responsibilities
- Review, file, and organize essential study documentation in the Trial Master File.
- Ensure documentation follows FDA and other regulations.
- Assist in identifying, addressing, and eliminating causes of non-compliance.
- Assist in preparing studies for audits.
- Assist in the annual review of company Standard Operating Procedures.
- Prepare documents for submission to the IRB (ethics review board).
- Prepare study documents for archiving and storage.
Benefits
- Medical, dental, vision, life, and disability insurance.
- Up to 4% match on the 401(k) plan and an HSA contribution.
- 13 paid holidays.
- Paid time off equivalent to 13 days per year.
- Mostly flexible work environment, with the ability to work from home as assigned.
- Growth potential and skill-building opportunities.
- Team environment described as one where employees work hard and have fun.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
