Regulatory and Quality Assurance Associate I

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory and Quality Assurance Associate I

Project Operations Full-Time Hourly Individual Contrib PEGUS Research - SLC, Salt Lake City, UT, US 1 Attachments

Salary Range: $17.50 To $20.00 Hourly

Regulatory Affairs and Quality Assurance Associate I - PEGUS Research - Salt Lake City, UT

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

Qualifications:

• 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.

Salary and Benefits:

• 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!