Regulatory and Quality Assurance Associate I

PEGUS RESEARCH INC

Salt Lake City, UTRemote OKFull time
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Pay
$18 to $20
an hour
Location
Salt Lake City, UT
Work style
Remote OK
Job type
Full time
Posted
Oct 19
1 day ago
Career path

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About the company

PEGUS RESEARCH INC

Research Services · 51 to 200 employees

Pegus Research Inc, is a unique, full-service OTC consumer behavior research organization. We specialize in label comprehension, self-selection, and actual use studies that lead to successful OTC approval. We provide expert, end-to-end support for Drug Facts Label development and testing, including consulting, support for FDA interactions, protocol design, study conduct, site selection and management, monitoring, data management, statistics, medical writing, and submission-ready data (CDISC) services.

PEGUS RESEARCH INC on LinkedIn

What you'll do

  • The associate will review and organize essential study documentation to ensure compliance with FDA regulations and GCP guidelines.
  • They will also assist in audit preparation, IRB submissions, and the maintenance of company standard operating procedures.

What you need

  • Candidates are required to have an associate degree, with a bachelor's degree preferred.
  • Strong written and verbal communication skills, proficiency in MS Office and Adobe Acrobat, and a detail-oriented mindset are essential.
  • Education: an associate degree or a bachelor's degree

Key skills

Regulatory affairsQuality assuranceDocumentationFDA regulationsGood clinical practiceTrial master fileIRB submissionAudit preparationStandard operating proceduresCommunication skillsMicrosoft OfficeAdobe AcrobatAttention to detailGood documentation practices

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Perks

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Disability insurance
  • 401(k) plan
  • HSA contribution
  • Paid holidays
  • Paid time off

See full description on company page, apply now

Read the full posting here
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:  * Associates degree required; bachelor’s degree preferred * 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! If you have these qualifications, and want to work for a unique company that has an impact on public health and consumer choice, please apply! To learn more about PEGUS, our team and our research studies, visit www.pegus.com.

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