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.
Responsible for providing scientific support to assist Study Directors with management of study conduct over the entire study life cycle.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provides scientific support to the Study Director team by assisting with many aspects of study conduct during the study life cycle, including planning and prioritization of deliverables to meet agreed deadlines.
Acquires knowledge of relevant processes and procedures established at Charles River Laboratories, Inc, including Standard Operating Procedures (SOPs).
Acquires knowledge of regulations and applicable Good Laboratory Practices (GLP).
Acquires knowledge of the study processes and the role of the Study Director.
Acquires knowledge of the animal ethical/IACUC process and the Quality Assurance (QA)/Quality Control (QC) process.
Attends study-related and/or department-related meetings to assure understanding of assigned projects including objectives, timelines, and reporting requirements.
May assist with reviewing draft protocols and amendments and preparing Animal Use Proposal Forms.
Participates in study oversights by observing various study procedures.
Prepares for client visits and participates in hosting clients while onsite.
Prepares study information summaries for Toxicokinetic Principal Investigators.
May assist with study investigations, documentation of deviations from the study plan/protocol or SOPs, preparation of summary data/tables for Sponsor updates and management of QA audits from Test Sites.
Assists with report finalization by initiating/completing finalization assessment forms, performing QC of final reports, and drafting/reviewing Common Technical Documents.
May assist with generation and review of historical control data.
May attend scientific meetings, conferences, or training courses to enhance job and professional skills.
May participate in cross-functional teams/working groups.
Performs all other related duties as assigned.
The pay range for this position is between $26.50 and $27.50/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
QUALIFICATIONS:
Education/Experience: Master’s with 0-1 year experience or B.S. with 2-3 years experience. Experience within a preclinical service environment is 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: Advanced skills in spreadsheet, word processing, database, and publishing software (e.g.: MS Excel®, Word®, and Adobe® Acrobat® PDF software) preferred. Familiar with non-clinical study protocols/reports and GLP regulations. Strong written, verbal, analytical and communication skills.
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.
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