GLP Data Review & Compliance Specialist

RADgov Inc.; Shrewsbury (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

RADgov Inc. in Shrewsbury, MA is seeking a Data Reviewer to ensure study data is complete and GLP compliant. You will review data for SOP adherence and regulatory guidelines, collaborating with Scientists and QA staff.

The role involves data review of paper and electronic sources, updating forms, and communicating issues to department management. Strong attention to detail and teamwork are essential.

Qualifications

• Education: High school diploma or GED required; Associates degree preferred.
• Strong organizational, communication and listening skills with acute attention to detail.
• Basic understanding of SOPs, FDA GLPs and GCP and other applicable regulatory guidelines.
• Ability to work effectively as a member of a team.
• Proficient computer skills; familiarity with Microsoft Office, especially Word and Excel.
• Ability to work effectively under minimum direction.

Responsibilities

• Complete data review on all paper and electronic data produced in operational departments.
• Ensure all forms that require data review and electronic data are in compliance with SOPs and forms are updated as needed.
• Ensure data corrections are completed by the appropriate staff and correctly.
• Communicate with department management and Scientist regarding data collection issues.
• Assist in departmental training on data notation and correction as it relates to study data review.
• Assist in revising and developing department forms.
• Archive, collate, and organize all completed data and files.
• Interact with Scientist regarding data and collaborate with QA to ensure GLPs are followed.

Skills

Data review

Attention to detail

Regulatory knowledge

Team collaboration

Communication

MS Office

Education

High school diploma or GED

Associates degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

RADgov Inc. in Shrewsbury, MA is seeking a Data Reviewer to ensure study data is complete and GLP compliant. You will review data for SOP adherence and regulatory guidelines, collaborating with Scientists and QA staff.

The role involves data review of paper and electronic sources, updating forms, and communicating issues to department management. Strong attention to detail and teamwork are essential.