For 70 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

We are seeking a SCIENTIFIC COORDINATOR for our Safety Assessment Group site located in ASHLAND, OHIO.

Provide protocol and report support to study directors, and assist with providing information/data requested by sponsors. Assist with management of QA audits and assure necessary corrections and follow-up take place.

Responsibilities:

• 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.
• With guidance, 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.
• Create/generate special tables for sponsors as needed.
• 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.
• 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). Assist in drafting new or study specific SOPs.
• Perform all other related duties as assigned.

Qualificiations:

• Bachelor’s degree (B.A./B.S.) or equivalent in science or related discipline.
• 2-4 year 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.
• 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.

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 120 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 14,000 employees within 80 facilities in 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. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

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 ~85% of the drugs approved by the FDA in 2018.

EQUAL EMPLOYMENT OPPORTUNITY

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

NEAREST MAJOR MARKET: Cleveland

NEAREST SECONDARY MARKET: Mansfield

JOB SEGMENT: Chemistry, Analytics, Scientific, Toxicology, Biotech, Science, Engineering, Management

Charles River Laboratories is a visionary leader in the development and delivery of advanced drug therapies. We provide essential products and services to pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe, to help accelerate their research and drug development efforts. At Charles River, we view every day as an opportunity to improve global health and people's lives. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.