IVD Clinical Trials Field Lead

Biotech Partners Inc; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Biotech Partners Inc. seeks a Clinical Research Associate (CRA) to execute clinical studies across the product lifecycle, including pre-launch evaluations and post-market studies. You will coordinate with clinical sites and support instrument implementation to ensure high-quality data per study protocols.

This is a field-oriented role requiring extensive travel and collaboration. The ideal candidate combines clinical research experience with laboratory instrumentation knowledge and strong

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, Medical Technology/MLS.
• Clinical Research Associate (CRA) certification or equivalent qualification.
• Minimum of 2 years coordinating or monitoring IVD clinical trials.
• At least 2 years in a clinical laboratory, diagnostic company, or related environment.
• Technical understanding of automated clinical laboratory systems and instrumentation.
• Experience with statistical and data-analysis tools for method evaluation and clinical study data.

Responsibilities

• Coordinate and support IVD clinical trials and product evaluations at hospital and clinical lab sites.
• Ensure site activities follow study protocols and clinical objectives.
• Establish and maintain relationships with participating and prospective sites.
• Coordinate study-site readiness including instrument installation and study materials.
• Train personnel on diagnostic instruments and study procedures.
• Provide on-site support and troubleshoot study-related issues.
• Manage handling, tracking, storage, and disposition of investigational products.
• Assist with data collection, review, and analysis of study data onsite.
• Maintain complete clinical study documentation and site files.
• Contribute to study reports, technical documentation, and publications.
• Assist with protocol evaluations in simulated environments.
• Collaborate with clinical, scientific, technical, and product teams.

Skills

Strong communication

Independent work

Cross-functional collaboration

Complex concepts communication

Education

Bachelor's degree in Biology, Biochemistry, Chemistry, Medical Technology/MLS

CRA certification or equivalent

Tools

Microsoft Office

Statistical analysis tools

Job description

Biotech Partners Inc. seeks a Clinical Research Associate (CRA) to execute clinical studies across the product lifecycle, including pre-launch evaluations and post-market studies. You will coordinate with clinical sites and support instrument implementation to ensure high-quality data per study protocols.

This is a field-oriented role requiring extensive travel and collaboration. The ideal candidate combines clinical research experience with laboratory instrumentation knowledge and strong