Senior Clinical Research Associate - Remote IVD Trials

Hbcu Connect, Llc; New York (NY); Remote; USD 103,000 - 130,000; Full time

Job summary

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to lead IVD/medical device trials at external sites across the United States. You will handle startup, initiation, monitoring, and close-out with emphasis on data integrity and compliance with FDA/GCP.

This fully remote role reports to Global Clinical Affairs and focuses on building relationships with investigators, vendors and internal stakeholders while supporting study planning, budgeting and regulatory documentation.

Qualifications

• Bachelor's degree with 5+ years clinical research experience OR Masters with 3+ years or Doctoral degree in field with clinical research experience
• Regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
• Previous experience managing clinical research sites and monitoring data
• Strong technical background to understand and communicate current and new technologies
• Ability to work on multiple projects simultaneously

Responsibilities

• Oversee protocol execution at external sites from start-up to close-out, ensuring data collection and GCP compliance
• Develop and maintain relationships with institutions, investigators, internal stakeholders, and vendors
• Conduct independent study monitoring, site coordination, product accountability, and assessments of deviations/adverse events
• Manage IRB submissions and regulatory documentation to keep Trial Master File audit-ready
• Contribute to study planning, budgeting, contracts, timelines, and process improvements

Skills

Clinical research

Regulatory knowledge

IRB submissions

Data integrity

Multitasking

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Doctoral degree with clinical research experience

Tools

eTMF

CTMS

Job description

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to lead IVD/medical device trials at external sites across the United States. You will handle startup, initiation, monitoring, and close-out with emphasis on data integrity and compliance with FDA/GCP.

This fully remote role reports to Global Clinical Affairs and focuses on building relationships with investigators, vendors and internal stakeholders while supporting study planning, budgeting and regulatory documentation.