Study Coordinator II
Posted on: February 16, 2020
Job Overview:We have a great opportunity for a?Study
Coordinator?on our BioAnalytical Team in Chantilly, VA.??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
Bachelor of Science (BS) degree in
science.Experience may be substituted for education.Efficient use
of word processing software, database, spreadsheet, and specialized
software.Proficient in concise writing; writing should require
little or no external review or edit.Adherence to grammar,
punctuation, composition, and spelling according to company
standard conventions.Experience on a variety of studies performed
in the department and exposure to a diverse client base.Knowledge
of regulatory agency guidelines.Experience:
Two years of Study Coordinator or
related experience.Excellent communication, presentation, and
interpersonal skills.Excellent attention to detail.Efficient in
prioritizing and managing time.
Keywords: Covance, Chantilly , Study Coordinator II, Other , Chantilly, Virginia
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