For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

JOB 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.

QUALIFICATIONS:

• Education: High school diploma or General Education Degree (G.E.D.) required. Associates Degree preferred.
• Experience: None.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None
• 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.

• 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.