Study Coordinator

 

Study Coordinator

The Study Coordinator is responsible for the technical oversight and execution of assigned laboratory studies within Nelson Labs. This role includes review, interpretation, analysis, documentation, and reporting of study results.

The Study Coordinator serves as the primary point of study control and ensures assigned studies are completed accurately, compliantly, and within established timelines.

 

Key Responsibilities

Study Execution & Oversight

• Conduct and monitor assigned sterilization studies, ensuring data accuracy and proper documentation.
• Analyze and interpret study data to ensure results are scientifically sound.
• Prepare study reports that clearly reflect results and conclusions.
• Support development and refinement of test methods, validation protocols, and Standard Test Procedures (STPs).

 

Quality & Compliance

• Follow GMP, GLP, ISO, and company procedures to ensure regulatory compliance.
• Document deviations and unexpected events and support corrective actions.
• Participate in quality investigations and continuous improvement initiatives.

 

Sponsor & Team Collaboration

• Act as a technical point of contact for assigned studies.
• Communicate progress and results to sponsors and internal teams.
• Work closely with laboratory staff to coordinate workflow, expectations, and study timelines.

 

What Makes You a Strong Fit

• Solid knowledge of sterilization validation principles and laboratory testing.
• Experience interpreting data, troubleshooting, and problem-solving.
• Excellent attention to detail and documentation practices.
• Strong organizational, time management, and communication skills.
• Customer-focused, collaborative, and proactive.
• Proficiency in Microsoft Office and laboratory information systems.

 

Work Environment & Physical Requirements

• This role operates primarily in a professional laboratory environment with routine use of standard lab and office equipment.
• Exposure to biological and chemical materials may occur; PPE is required (gloves, lab coats, safety glasses, etc.).
• Requires standing, walking, and sitting at a workstation; occasional bending, stooping, or lifting up to 45 lbs.

 

Education & Experience

• Bachelor’s degree in a life science discipline preferred; or
• Associate degree with relevant laboratory experience; or
• High school diploma/GED with significant laboratory experience and demonstrated test coordination proficiency.