Job Description:
GENERAL PURPOSE AND SCOPE:
• Performs activities related to the Project Management process
by coordinating activities for routine studies in compliance with
appropriate protocol, Standard Operating Procedure (SOP) and regulatory
agency guidelines, in a timely, efficient, and quality manner.
ESSENTIAL JOB DUTIES:
• Drafts protocols, sample analysis outlines (SAOs), amendments
and study schedules as appropriate, using proposal outline or
client-supplied information.
• Communicates and interacts with other departments and clients
as applicable.
• Updates project tracking systems as appropriate.
• Participates in pre-initiation and other study related meetings
as required.
• Aids in report preparation, including table and figure
preparation. Compiles analytical information from laboratory groups.
• Maintains well documented, organized, and up-to-date study
files including study schedule, protocol, and correspondence, as
applicable.
• Reviews QAU report audits. Submits audit responses for approval
as appropriate. Ensures that all necessary report/raw data clarifications
are completed.
• Reviews client comments with appropriate study personnel and
ensures that all necessary report/raw data clarifications are completed.
• Oversees report productions through finalization, including
archival of data as appropriate.
• Assists with routine client visits under direction of the Study
Director/Principal Investigator as requested.
OTHER JOB DUTIES:
• Performs other related duties as assigned.
