Preclinical Study Coordinator: GLP Compliance & Data Ops

INOTIV BOULDER LLC; Boulder (CO); On-site; USD 36,000 - 43,000; Full time

Benefits offered by this job

Health and dental coverage

401(k) plan

Paid time off

Parental leave

Job summary

Inotiv is seeking a Study Coordinator to support all functions of the preclinical study process. You will communicate with clients, study directors, and technicians, and work in a cross-functional, collaborative team to ensure study timelines and data integrity.

Key duties include submitting materials, coordinating with vendors, maintaining study files, ensuring GLP and regulatory compliance, and assisting with in-life study conduct.

Qualifications

• Bachelor's degree in life sciences or related field; minimum 3 years in a relevant pharmaceutical setting
• One year of animal handling experience required
• 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
• Ability to interact with scientific staff at all levels

Responsibilities

• Maintain and submit study initiation materials
• Communicate with key stakeholders including vendors and clients
• Order supplies for studies
• Coordinate study activities with other coordinators
• Ensure creation of data sheets
• Confirm lab math for test article and disease induction formulation
• Coordinate with formulation department on timelines/materials
• Assist with in-life study conduct as trained
• Complete training requirements and maintain documentation
• Review SOPs to ensure accuracy and conformity
• Participate in SOP writing, reviews and revisions
• 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 Inotiv documents
• Develop and maintain protocol, report, and data table templates
• Provide back-up support for Study Directors
• Aid in protocol/amendment/deviation preparation and distribution
• Prepare and review raw data collection forms for adherence to protocol
• Review raw data collection and in-life study conduct
• Assist to prepare a complete study file for archival
• Assist to ensure study samples and test articles are shipped on schedule and documented
• Perform other duties as assigned

Skills

Editing protocols/reports

Microsoft Office

Written & verbal communication

Attention to detail

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Office Suite

Job description

Inotiv is seeking a Study Coordinator to support all functions of the preclinical study process. You will communicate with clients, study directors, and technicians, and work in a cross-functional, collaborative team to ensure study timelines and data integrity.

Key duties include submitting materials, coordinating with vendors, maintaining study files, ensuring GLP and regulatory compliance, and assisting with in-life study conduct.