Study Coordinator

About The Role

Works under the guidance of designated Study Director(s), Contributing Scientists and Principal
Investigators, as appropriate, to provide administrative and professional support for accurate
study progression based on Protocols and Method Validation Plans, organization, scheduling,
reporting, client relations and operations.

What You’ll Do Here

• Assist with the preparation and distribution of Protocols, Analytical Study Plans and
  Amendments/Amended Protocols.
• Schedule and/or help conduct Protocol review meetings with Study Director guidance.
• Create study schedules for data collection within the electronic data capture system and
  implement schedule changes as a result of Protocol Amendments/Amended Protocols, as
  necessary.
• Draft and edit Project Review Forms (PRF) with Study Director guidance.
• Assist with preparation and maintenance of study notebooks, study forms, and other
  necessary materials for studies.
• Support the Study Director or Principal Investigator with the planning and hosting of client
  visits.
• Review raw data throughout the life of a study for clerical/technical errors, thoroughness
  and consistency, and adherence to SOPs, Protocol specifications and compliance with Good Laboratory Practices (GLPs), as appropriate. Coordinate correction of raw data with
  appropriate staff. Report any deviations to the Study Director.
• Coordinate study activities related to audits.
• Perform data verification as needed.
• Assist in the preparation of the report(s) (e.g. drafting the Materials and Methods section), utilizing the appropriate report template.
• Collect and collate report components for the final report under the supervision of the
• Study Director utilizing electronic publishing tools.
• Provide assistance with archiving and preparation of studies for finalization.
• Support the Study Director(s), Contributing Scientists and Principal Investigators with the monitoring, tracking and communication of study milestones throughout departments.
• Provide coordination for both non-GLP studies and GLP studies from study initiation to finalization under the guidance of the Study Director.
• Generate data tables for inclusion in reports based on requirements of the study.

What You’ll Need to Succeed

• A bachelors degree or college coursework in a scientific discipline and relevant experience may substitute for the educational requirement.
• 0 -1 years experience in a scientific environment or an equivalent combination of education and experience.
• General to advanced computer skills, including proficiency with Microsoft Word and Excel.
• Working knowledge of descriptive statistics.