Regulatory and Quality Assurance Associate I
PEGUS RESEARCH•Salt Lake City, UT
•Hybrid
About The Position
PEGUS Research is seeking a detail-oriented, motivated self-starter to join its Regulatory Affairs and Quality Assurance (RAQA) team. The 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-conduct principles. This role offers an early-career professional an opportunity to gain research experience and develop skills while contributing to work that supports public health and consumer healthcare choices.
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 Microsoft 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 and ability to take initiative and work independently as needed.
- Good interpersonal skills.
Nice To Haves
- Bachelor’s degree preferred.
- Knowledge of Good Documentation Practices is a plus.
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 with 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 insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan with up to 4% company match
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
