Scientific Coordinator-Lab Sciences

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.

We are seeking a Scientific Coordinator for our Safety Assessment site located in Reno, NV.

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.

• 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).

The pay range for this position is $25.00 USD per hour. Please note that salaries vary within the range…