Study Coordinator

Inotiv•Boulder, CO

About The Position

The Study Coordinator reports to the Study Coordinator Supervisor within the In Vivo Department with responsibilities centered around supporting all functions of the preclinical study process. The ability to communicate succinctly with clients, study directors and technicians is key as is a cross-functional, flexible, and collaborative spirit.

Requirements

Bachelor's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of 3 years in a relevant pharmaceutical setting
One year animal handling experience required
Possess strong skills for editing the format, style and language of draft protocols, spreadsheets and reports
Experience using Microsoft Office (Word, Excel, Outlook)
Excellent written and verbal communication skills
An attitude for quality, an eye for detail and the ability to read and follow written instructions
Ability to interact with scientific staff at all levels

Responsibilities

Maintain and submit study initiation materials
Communicate effectively with all key stakeholders including vendors and clients
Order all applicable supplies for studies
Communicate with other coordinators to schedule study activities
Insure creation of data sheets
Confirm lab math for test article and disease induction formulation
Communicate with formulation department regarding timeline and materials needed
Assist with in-life study conduct, as needed, and as trained
Complete training requirements as assigned and maintain appropriate training documentation
Perform periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs.
Participate in SOP writing, reviews, and revisions, as needed
Maintain compliance with all policies and procedures
Ensure compliance with GLPs, USDA, AAALAC, OLAW and other applicable regulations
Perform quality checks, reviews, and formatting on all Inotiv documents (e.g. protocols, amendments, deviations, reports, tables, etc)
Develop and maintain protocol, report, and data table master templates
Provide back-up support for Study Directors as needed
Aid in protocol and any protocol amendment or deviation preparation and distribution
Prepare and review raw data collection forms and review for adherence to protocol, both prior to study start and after study completion
Review raw data collection and in-life study conduct
Assist to prepare a complete study file for archival following finalization of report
Assist to ensure that study samples and test articles are shipped appropriately, on schedule, and documented in the study file
Perform other duties as assigned