Do you have a passion for Science? Writing? Accuracy? Please keep reading...
We have a great opportunity for an Associate Study Coordinator in our Drug Metabolism Department at our Madison, WI lab. Covance's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
In this role, you will be responsible for coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner.
Duties and Responsibilities :
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 and communicates work 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
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, organized 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 applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
Assists in interpreting and evaluating data for reports
Participates in the peer review process for scientific reports
Reviews QAU report audit sand client comments with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
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. Learns to host routine client visits and interacts/communicates with client as necessary.
Maintains an awareness of the financial status of ongoing studies, including work scope changes
Begins to act as a basic project coordinator for assigned clients(s) across the metabolism discipline
Relevant degree (i.e. Life Sciences) plus 2 years of appropriate experience; relevant experience may be substituted for academic qualifications.
Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.
Skilled in the use of standard laboratory equipment.