Study Coordinator II
Posted on: July 17, 2021
We have a
great opportunity for a Study
Coordinator on our BioAnalytical Team in
Chantilly, VA. Lapcorp Drug
Development'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.
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
drafts protocols, sample analysis outlines (SAOs), amendments and
study schedules as appropriate, using proposal outline or
study compliance against protocol, SOP, and regulatory agency
- Learns to
serves as the primary contact in communication and interaction with
other departments and clients as applicable.
and maintains project tracking systems as appropriate.
in and assists Study Director/Principal Investigator (SD/PI) with
pre-initiation and other study related meetings, including
scheduling and leading meetings as required.
- Learns to
manage increasingly complex projects and study designs and/or
increased study load.
for report preparation, including table and figure
in evaluating data for reports.
well documented, organized, and up-to-date study files including
study schedule, protocol, and correspondence, as
QAU report audits and submits audit responses for approval as
client comments and makes decisions, including appropriate study
personnel as necessary, to ensure that all necessary report/raw
data clarifications are completed.
for report production through finalization, including archival of
data as appropriate.
with routine client visits as requested. Manages data transfer to
clients as requested.
SD/PI in monitoring study phases.
other related duties as assigned.
of Science (BS) degree in science.
may be substituted for education.
use of word processing software, database, spreadsheet, and
in concise writing; writing should require little or no external
review or edit.
to grammar, punctuation, composition, and spelling according to
company standard conventions.
on a variety of studies performed in the department and exposure to
a diverse client base.
of regulatory agency guidelines.
- Two years
of Study Coordinator or related experience.
communication, presentation, and interpersonal skills.
attention to detail.
in prioritizing and managing time.
Keywords: Labcorp, Chantilly , Study Coordinator II, Other , Chantilly, Virginia
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