Study Coordinator, Safety Assessment
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.
The Study Coordinator works under the guidance of designated Study Director(s), Contributing Scientists and Principal Investigators, as appropriate, to provide administrative support for accurate study progression based on the study protocols and/or method validation plans, organization, scheduling, reporting, client relations and operations.
- Assist with the preparation and distribution of Protocols, Analytical Study Plans and Amendments
- Schedule and/or help conduct protocol review meetings with Study Director guidance
- Create study schedules for data collection within the online data capture system and implement schedule changes as a result of protocol amendments, as necessary
- Assist with drafting of 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, Analytical Study Director or lead Study Coordinator with the planning 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 Generate data tables for inclusion in reports based on requirements of the study
- 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
- Collects and collates report components for the final report under the guidance 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 short term, acute, non-GLP studies from study initiation to finalization under the guidance of the Study Director
- May also be responsible for coordination for GLP studies
- A Baccalaureate degree. College coursework in a scientific discipline and relevant experience may substitute for the educational requirement.
- 1+ years experience in a scientific environment or an equivalent combination of education and experience
- General to advanced computer skills: proficiency working with MS Word and Excel.
- Ability to multi-task and maintain organization in a fast paced, changing environment. Strong planning and organizational skills
- Ability to work effectively and cooperatively in a team environment under significant time pressure
- Demonstrated attention to detail and consistent ability to operate with accuracy and quality
- Job Family Valide Positions
- Pay Type Hourly
- Job Start Date Monday, November 2, 2020
- Everett, WA, USA