Study Coordinator (I) Dose Analysis
We are seeking talented science majors in the fields of Biology, Biochemistry, Chemistry and similar majors to work as a Study Coordinator (I) in Madison, WI.
In this role, you will be responsible for coordinating the activities of routine dose analysis studies in compliance with appropriate company standards, GLP and regulatory guidelines specified in the study plans, protocols or work agreements. Our mission is to improve lives and bring new medicines to market.
Duties and Responsibilities:
- Drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
- Communicates and interacts with study team, other departments and clients as applicable
- Assist in planning, prioritization and management of workload and multiple responsibilities.
- Uses project tracking systems as appropriate with some oversight.
- Attend and participate in pre-initiation and other study related meetings as required.
- Aids in report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
- Learns to interpret and evaluate data for reports.
- Aids in maintaining well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
- Learns to respond to QAU report audits and how to ensure that all necessary report/raw data clarifications are completed. Learn to submit audit responses for approval as appropriate.
- Learns to review client comments with appropriate study personnel and how to ensure that all necessary report/raw data clarifications are completed
- Aids in report production processes through finalization, including archival of data as appropriate.
- Learns to assist with routine client visits under direction of the Study Director/Principal Investigator as requested.
- Contributes to a cohesive team environment.
- Supports process improvement initiatives.
- Assists with the management of data transfer to clients as requested.
- Schedules study phases in coordination with SD/PI and lab operations.