Scientist III

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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.

Complete understanding of regulatory compliance and assigned department study data/reports. Excellent verbal and written communication skills. Provide protocol and report support to project scientists and information/data requested by sponsors. Assist with management of QA audits and ensure necessary corrections and follow-up take place. Manage multiple studies of varying complexity, concurrently.

• Create, customize, and monitor planning tools to facilitate prioritization of daily activities (i.e., Smartsheet, RPM, M-files, etc.).
• Maintain study and inventory trackers in support of departments.
• 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.
• May serve as primary point of contact to the sponsor when project scientist is not available.
• Efficiently performs and documents QC review of study data and associated audit trails (as applicable), tables, and reports in compliance with applicable regulatory standards, SOPs and company policies, with minimal errors, while identifying processes for improvement. Conducts review of complex QC submissions independently.
• Independently, create/generate special tables and files to support analysis for sponsors, as needed.
• Ensure that all study books are corrected appropriately, and that documentation is compliant prior to submission to QA/data central.

• Independently, document deviations from the protocol or Standard Operating Procedures (SOP). Assist in drafting new or study specific SOPs.
• Independently, review and document all study data, procedures, materials and results in compliance with applicable regulatory standards, SOPs, and methods/protocols.
• Maintain a high level of effective communication skills through informal discussions with peers, supervisor, team and Sponsor/Project Scientist.
• Ensure documents align with requirements indicated in Client Information Database (CID).
• Assist with management of QA audits and ensure necessary corrections and follow-up take place.
• On an as needed basis, 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 objections, timelines, and reporting requirements, as appropriate for scope.
• Independently develop, review, and update QC guidance documents, SOPs and data check forms. Assist other staff with reviewing and updating documents.
• Assist with generating results, providing study updates and presentation of study data.
• Recommend form and SOP modifications, and changes to standard protocol wording to avoid deviations in collaboration with lab management.
• Develop and oversee periodic training programs with departmental personnel; communicate QC questions, observations, and goals.
• Teach and mentor personnel concerning proper, timely QC practices.
• The pay for this position is between $35.00 - $38.00/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

• Education: Bachelor’s degree…