Scientific Support

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

Location: Shrewsbury, Massachusetts 01532, USA

Description:

40 hour work week (Potential for OT but may not be required)

See additional task as well

interview- onsite preferred; 1 round

BASIC SUMMARY:

Responsible for reviewing all study data to ensure it is complete and GLP compliant. Ensure that all

data received for review follows SOP and regulatory guidelines that apply to the recording of study

data. Interact with Scientist, QA staff and other departments with regards to data.

ESSENTIAL DUTIES AND 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 Standard Operating Procedures (SOPs) and forms are updated as needed.
• Ensure all data corrections are completed by the appropriate staff members and that they are completed correctly.
• Communicate with department management and Scientist regarding any issues related to data collection that impact the recording of data.
• Assist in departmental training by providing assistance with training on correct methods of data notation and correction as it relates to study data review.
• Assist in revising and developing department forms.
• Archive, collate, and organize all completed and reviewed data and/or file as appropriate.
• Interact with the Scientist regarding data that is received for review. Collaborate with QA staff to ensure GLPs are being followed for the recording of data.
• Assist with department filing as needed.
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: High school diploma or General Education Degree (G.E.D.) required. Associates Degree preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Other: Strong organizational, communication and listening skills with acute attention to detail. Basic understanding of processes used for study data collection. Basic understanding of SOPs, FDA GLPs and GCP and other applicable regulatory guidelines governing the recording and review of study data. Basic understanding of algebraic math and scientific concepts. Ability to work effectively as a member of a team. Experienced computer skills; familiarity with Microsoft Office software and specifically with Word and Excel. Ability to work effectively under minimum direction.

PHYSICAL DEMANDS:

• Regularly operates a computer and occasionally operates other office productivity machinery such as a label maker, copy machine, and computer printer.
• Regularly communicates with employees.
• Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to exchange accurate information in these situations.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.
• Regularly moves about inside the office to access file cabinets, office machinery, etc.

WORK ENVIRONMENT:

• General office and laboratory working conditions, the noise level in the work environment is