Data Review Assistant - Immunology

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.

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.

Job Qualifications

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.

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 usually quiet.

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.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.