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.
- 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.
About Safety Assessment
- 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.
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.