Covance Assist Study Coord, Metabolism in Madison, Wisconsin

Job Overview

Covance is seeking an Assistant Study Coordinator to join its Study Management Team in Greenfield, IN.

  • 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

  • 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 a contact, along with the Study Director, in communication and interactions with other departments and clients, with assistance 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 the development and maintenance of standard report/table formats as required

  • Assists in interpreting and evaluating data for reports

  • Participates in the 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 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. 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 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 or lead optimization disciplines

  • Performs other related duties as assigned.

Education/Qualifications

  • Relevant degree plus 2 years of appropriate experience. Relevant experience may be substituted for academic qualifications.

Experience

  • Ability to utilise word processing, databases, spreadsheets, and specialised software on personal computers.

  • Skilled in the use of all standard laboratory equipment

Job Number 2018-20968

Job Category Scientific Bachelor's Degree

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.