RAQA Associate I: Flexible Hours + Growth in Compliance

PEGUS Research, Inc.; Salt Lake City (UT); Hybride; USD 24 000 - 28 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) match

HSA contribution

Paid holidays

Paid time off

Work from home

Growth opportunities

Team environment

Résumé du poste

PEGUS Research, Inc. is seeking a detail-oriented Regulatory and Quality Assurance Associate I for the Salt Lake City area. The role supports the RAQA team by handling essential study documentation and ensuring compliance with FDA regulations and GCP guidelines.

Responsibilities include maintaining the Trial Master File, assisting audits, SOP reviews, and preparing submissions to ethics boards. This is an early-career opportunity with growth potential in a fast-paced research environment.

Qualifications

• Strong written and verbal communication skills.
• Organized, detail oriented, and able to learn quickly.
• Ability to work independently and take initiative.
• Knowledge of Good Documentation Practices is a plus.

Responsabilités

• Reviews, files, and organizes essential study documentation in the Trial Master File.
• Ensures documentation follows FDA and other regulations.
• Assists in 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.

Connaissances

Communication skills

Attention to detail

Organizational skills

Independent work

MS Office

Adobe Acrobat

Outils

MS Office

Adobe Acrobat

Description du poste

PEGUS Research, Inc. is seeking a detail-oriented Regulatory and Quality Assurance Associate I for the Salt Lake City area. The role supports the RAQA team by handling essential study documentation and ensuring compliance with FDA regulations and GCP guidelines.

Responsibilities include maintaining the Trial Master File, assisting audits, SOP reviews, and preparing submissions to ethics boards. This is an early-career opportunity with growth potential in a fast-paced research environment.