Remote Senior Clinical Research Associate – IVD Trials

Sunseeker Property Service; New York (NY); Remote; USD 103,000 - 130,000; Full time

Benefits offered by this job

Remote work option

Benefits: PTO, medical/dental/vision,

401(k)

Job summary

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to oversee IVD and medical device trials at external sites. The role is fully remote within the United States and reports to the Manager, Clinical Site Operations in Global Clinical Affairs.

You will train and manage external sites, monitor data quality, handle regulatory documents, and contribute to planning, budgeting, and process improvements. Travel up to 70% may be required during initiation periods.

Qualifications

• Bachelor’s degree with 5+ years clinical research experience or Master’s with 3+ years, or Doctoral degree with clinical research experience.
• Knowledge of regulatory requirements and Good Clinical Practice for IVD/medical devices.
• Experience managing clinical research sites and monitoring study data.
• Ability to communicate current and new technologies clearly.
• Ability to manage multiple projects concurrently.

Responsibilities

• Oversee study protocol execution from start-up to close-out at external sites.
• Develop and maintain relationships with institutions, investigators, and vendors.
• Conduct independent study monitoring and assess deviations/adverse events to ensure data quality.
• Manage IRB submissions and ensure Trial Master File is audit-ready.
• Contribute to study planning including budgets, contracts, timelines, and templates.

Skills

Clinical research

Regulatory knowledge

Multi-project management

Communication of tech

Education

Bachelor’s degree in clinical research or related field

Master’s degree in clinical research or related field

Doctoral degree in field with clinical research experience

Tools

Electronic Trial Master Files

Clinical Trial Management Systems

Job description

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to oversee IVD and medical device trials at external sites. The role is fully remote within the United States and reports to the Manager, Clinical Site Operations in Global Clinical Affairs.

You will train and manage external sites, monitor data quality, handle regulatory documents, and contribute to planning, budgeting, and process improvements. Travel up to 70% may be required during initiation periods.