Regulatory and Quality Assurance Associate I
RemoteHunter
United States0–2 yrs4m agovia LinkedIn
About the Role
The Regulatory and Quality Assurance Associate I plays a critical role in maintaining compliance and quality in clinical research studies. This position supports the Regulatory Affairs and Quality Assurance team by managing essential documentation, ensuring adherence to FDA regulations and Good Clinical Practice (GCP) guidelines, and assisting in audit preparations.
Key Responsibilities
- Review, file, and organize essential study documentation in the Trial Master File
- Ensure documentation complies with FDA and other regulatory requirements
- Assist in identifying, addressing, and eliminating causes of non-compliance
- Support preparation of studies for audits
- Assist in annual review of Standard Operating Procedures (SOPs)
- Prepare documents for submission to Institutional Review Boards (IRBs)
- Prepare study documents for archiving and storage
Requirements & Tech Stack
- Proficiency with MS Office and Adobe Acrobat
- Knowledge of Good Documentation Practices (GDP) is a plus
Qualifications
- Associate degree required; bachelor's degree preferred
- Strong written and verbal communication skills
- Highly organized and detail-oriented with quick learning ability
- Initiative and ability to work independently
- Good interpersonal skills