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** + **The pay range for this position is $25.00 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.** Responsible for providing protocol and report support to Study Directors, and scientists, and assist with providing information/data requested by sponsors. Publish data tables and develop Material and Methods. Assist with management of QA audits and assure necessary corrections and follow-up take place. * Attend post-award and/or pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results, including objectives, timelines and reporting requirements. * Create/customize planning tools to facilitate prioritization of daily activities. * Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits. Serve as primary point of contact to the sponsor when study director is not available. * Write initial protocol drafts. Upon study director approval, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process. * Facilitate signature/approval process for protocol, amendments and other required forms. * Tabulate study data and schedule data review meetings. * Extract information from protocol and study data to generate the materials and methods sections of preclinical study reports and/or clinical subreports including text tables. * Create data tables for report from automated data collection systems or manual data if applicable. * Create/generate special tables for sponsors as needed. * Generate and format data tables for reports. * Create interpretive tables as directed by the study director. * Maintain reporting timelines. * Assemble report (text and data tables) for senior scientific review, QA audits, and final report compilation. * Assist with management of QA audits and assure necessary corrections and follow-up take place. * Answer QA audit findings as directed by the study director. * Ensure that all study books are corrected appropriately, and that documentation is GLP compliant prior to submission to QA. * Assist in IACUC form preparation and perform IACUC literature searches. * Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOP). * Work closely within a small team environment. * Perform all other related duties as assigned. * Under direction of the study director, receive, review and accept proof corrections from report coordination staff and make recommended corrections as appropriate. * Provide editorial/formatting review of final study protocols, amendments and report text. Provide comments and/or suggested changes to study director. * Upload data/reports to CR Sponsor portal and/or Sponsor portal. **Job Qualifications** ***** **Education:** Bachelor's degree (B.A./B.S.) or equivalent in science or related discipline. * **Experience:** 1-3 years related experience in a laboratory or scientific research environment. * 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:** This position requires analytical thinking skills and a good understanding of scientific processes. Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. Must be familiar with medical terminology and have a thorough understanding of technical aspects of research studies (e.g. observing dosing, treatments, surgical procedures, and necropsy evaluations). **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. **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. 229182