Associate Study Coordinator- PK/TK Team
Covance is currently seeking an Associate Study Coordinator for the Pharmacokinetic/Toxicokinetic (PK/TK) team at the Madison, WI site.
This position offers the opportunity to learn pharmacokinetics and toxicokinetics while also gaining client facing exposure. We are seeking motivated, career minded individuals who are interested in building a career with Covance and the PK/TK team. The Study Coordination team offers a detailed and structured career pathway that provides the opportunity for rapid and accelerated advancement for determined individuals. Benefits include medical, dental, 401k, 21 days paid time off (plus additional holidays), community involvement opportunities, internal training, and tuition reimbursement!
As an Associate Study Coordinator your job duties will include:
• Performs initial review of analytical data and originates non-compartmental analysis in support of pharmacokinetic and toxic kinetic studies
• Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
• Assists in interpreting and evaluating data for reports
• 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 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 the PK/TK study phase, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
• Assists in the development and maintenance of standard report/table formats as required
• Participates in the editing 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 deputize 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.
• 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.
• Maintains an awareness of the financial status of ongoing studies, including work scope changes
• Develops an area of expertise within the department and serves as a resource by providing training and 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
• Trains and mentors less experienced staff
• Able to review work of others for overall accuracy, timeliness, completeness and soundness of technical judgment.
• Performs other related duties as assigned.