Covance Associate Study Coordinator- Metabolism in Madison, Wisconsin
Associate Study Coordinator-Metabolism
Drafts protocols, amendments and study schedules as appropriate using study outline or client supplied information
Reviews study compliance against protocol, SOP and regulatory agency guidelines
Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases andcommunicateswork plan to laboratory personnel and support groups, as applicable.
Participates in and assists SD/PI with pre-initiation and other study related meetings as required
Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.
Proactively communicates and interacts with study team (SD’s and operational staff) to ensure key milestones are achieved
Serves as the primary contact in communication and interaction with other departments and clients as applicable
Maintains well documented, organised and up-to-date study files including study schedule, protocol and correspondence.
Assists SD/PI in monitoring in-life and analytical phases of studies, if applicablecompliance with protocol, SOPs and regulatory guidelines.
Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
Assists in the development and maintenance of standard report/table formats as required
Assists in interpreting and evaluating data for reports
Participates in the peer review process for scientific reports
Reviews QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
Learns to deputise for SD in their absence with ability to provide updates to internal/external customers
Reviews client comments and makes decisions in conjunction with SD/PI and ensures that all necessary report/raw data clarifications are completed.and review of study
Regularly manages increasingly more complex projects and study designs and/or increased study load
Responsible for and drives report production through finalization, including archiving of data as appropriate.
Prepares for and participates in routine client visits under direction of the SD/PI. Hosts routine client visits and interacts/communicates with client as necessary.
Maintains an awareness of the financial status of ongoing studies, including workscope changes
Develops an area of expertise within the department and serves as a resource by providing training an written instructions
Develops knowledge of Covance metabolism capabilities such that they can coordinate (with supervision) one other area outside of their area of expertise
Learns to expand responsibilities as a project coordinator for assigned clients(s) across the metabolism discipline
Performs other related duties as assigned.
- Relevant degree plus 4 years of appropriate experience. Relevant experience may be substituted for academic qualifications.
Solid Computer Skills
Ability to utilise word processing, databases, spreadsheets, and specialised software on personal computers.
Skilled in the use of all standard laboratory equipment
Job Number 2018-18294
Job Category Scientific Entry Level
Position Type Full-Time
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