Clinical Study Monitor

Position Summary:

• Oversees day-to-day execution and monitoring of clinical studies for IVD devices focusing on companion diagnostics.
• Ensures studies meet protocol, SOPs, and regulatory requirements while prioritizing data quality and subject safety.

Primary Responsibilities:

• Execute monitoring activities including source data verification, essential document review, and specimen tracking.
• Prepare clear monitoring visit reports and track findings through resolution.
• Support IRB/EC submissions and manage Trial Master File documentation.

Qualifications:

• BA/BS in life sciences or related field with 4+ years clinical research experience.
• Strong knowledge of GCP, ISO 20916, IVDR, and FDA regulations.
• Ability to travel up to 40% for site visits and audits.