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.
ESSENTIAL DUTIES AND 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.Qualifications
•Education: Bachelor’s degree (B.A. /B.S.) or equivalent in science or related discipline.
•Experience: 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.
•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).
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet