Data Review Assistant I, ACS

2 weeks ago

Reno, United States Charles River Full time

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

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 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.


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. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

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 have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

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