What are the responsibilities and job description for the Data Review Assistant position at Charles River Laboratories?
For 70 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
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 guidelines that apply to the recording of study data. Interact with Quality Assurance staff as needed.
- 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 supervisors 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 Quality Assurance 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.
- Complete intermittent checks on study activities to ensure that documentation of data being collected is in compliance with SOPs and GLPs.
- Perform all other related duties as assigned.
Job Qualifications
QUALIFICATIONS:
- Education: High school diploma or General Education Degree (G.E.D.).
- Experience: Minimum of 1 year related experience. Experience in an animal research facility preferred. GLP experience preferred.
- 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 skills and acute attention to detail. Basic understanding of processes used for study data collection. Basic understanding of SOPs, GLPs and other applicable regulatory guidelines governing the recording and review of study data.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
