Covance is currently seeking a Study Coordinator III in the BioA group in Indianapolis, IN.
- Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.
- Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
- Assists in the development of new report formats as needed.
- Improves processes to increase the efficiency of daily/routine procedures and reporting methods.
- Serves as the primary contact in communication and interaction with other departments and clients as applicable.
- Updates and maintains project tracking systems as appropriate.
- Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
- Responsible for report preparation, including table and figure preparation.
- Assists in evaluating data for reports.
- Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.
- Reviews QAU report audits and submits audit responses for approval as appropriate.
- Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
- Responsible for report production through finalization, including archival of data as appropriate.
- Prepares for and participates in routine client visits.
- Manages data transfer to clients as requested.
- Assists SD/PI in monitoring study phases.
- Assists with training and mentoring less experienced staff.
- Performs other related duties as assigned.