Posted on: June 14, 2019
Job Overview Do you have a passion for Customer Service? Project
Management? Multi-tasking? Writing? Attention to Detail? Please
keep reading--- We have a great opportunity for a Study Coordinator
on our BioAnalytical Team in Madison, WI. 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 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. Essential Job Duties:
- 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
- Learns to serves as the primary contact in communication and
interaction with other departments and clients as applicable.
- Updates and maintains project tracking systems as
- Participates in and assists Study Director/Principal
Investigator (SD/PI) with pre-initiation and other study related
meetings, including scheduling and leading meetings as
- Learns to manage increasingly complex projects and study
designs and/or increased study load.
- Responsible for report preparation, including table and figure
- Assists in evaluating data for reports.
- Maintains well documented, organized, and up-to-date study
files including study schedule, protocol, and correspondence, as
- 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.
- Assists with routine client visits as requested. Manages data
transfer to clients as requested.
- Assists SD/PI in monitoring study phases.
- Performs other related duties as assigned.
- Bachelor of Science (BS) degree in science or related
- Experience may be substituted for education.
- Ability to utilize word processing software, database,
spreadsheet, and specialized software. Experience
- Minimum of 1.5 years of related experience.
- Excellent communication, presentation, and interpersonal
- Excellent attention to detail.
- Ability to prioritize and manage time.
Keywords: Covance, Madison , Study Coordinator-BioA, Other , Madison, Wisconsin
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