The Study Coordinator
assists in performing project critical activities with
supervision/oversight
from the Project Manager and department management.
Primary activities
include: (1) performing quality review of data tables, reports
and all study supporting
documentation for accuracy and adherence to SOPs, GLP
guidelines, and
established laboratory policies and (2) identifying issues and
deviations that
affect the quality of study-related data and communicating
these to the Project
Manager or appropriate department manager.
Qualifications:
Minimum of a
Bachelor’s Degree in the Biological Sciences or equivalent
experience
preferred. Minimum of 1 year in a QC/QA role at another GLP,
GMP
facility. Minimum 1 year in an analytical laboratory
environment which is
under GLP regulation. Immunochemistry experience is
required. Extremely
strong competence using Microsoft Word and Excel especially
with various
formatting features. Functional knowledge of Watson LIMS
a
plus. Must be detail oriented, well
organized with
exceptional communication skills. Must have sufficient
scientific background to
understand scientific concepts of ligand binding assays
(biomarkers, PK,
immunogenicity and cell-based assays). Must be familiar with
all with GLP requirements.
Corporate
Responsibilities:
• Adherence to
laboratory health and safety
• Adherence to
Standard Operating Procedures (SOPs)
• Adherence to
applicable company policies and guidelines
• Adherence to federal
and/or local regulations as applicable
• Review run folders,
notebooks and other study-related materials and document
deviations from SOPs,
regulations and/or client specifications
• Assure that all QC
and QA findings are responded to in a timely fashion and are
complete and
accurate.
• Assure that all run
folders and data tables move through the internal process
including the Quality
Assurance department in sufficient time to meet client
timelines.
• QC review data
summary tables from Watson LIMS and various Excel spreadsheet
formats.
• Attend client
conference calls and prepare/provide agenda and meeting
minutes when
required.
• Other duties as
assigned.
Additional
Requirements:
• Knowledge of
GLP.
• Ability to
multi-task and participate in multiple studies
concurrently.
• Ability to ensure
high quality data while working under the pressure of strict
deadlines.
• Overtime and weekend
work as required.
• Work may require the
use of PPE (personal protective equipment).
Professional
Responsibilities: (if applicable)
• Attend continuing
education courses, as appropriate.
Qualifications
Education
Preferred
Associates or
better in Biology.