Data Review Assistant

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.

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.

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.

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.

The pay for this position is $18.50/hr.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.