Senior Clinical Research Associate

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

This position will play a hands-on role in the execution of clinical studies throughout the product lifecycle, including pre-launch/beta evaluations, post-market studies, and studies supporting expanded product claims. The CRA will work directly with participating clinical sites, coordinate study activities, support instrument implementation and training, and help ensure high-quality clinical data is generated in accordance with study protocols.

This is an excellent opportunity for someone who combines clinical research experience with a strong understanding of diagnostic laboratory instrumentation and assays and is comfortable working directly with laboratory personnel at study sites.

Key Responsibilities

• Coordinate and support IVD clinical trials and product evaluations at hospital and clinical laboratory sites across the U.S. and internationally.
• Ensure site activities are performed in accordance with study protocols, clinical objectives, and applicable requirements.
• Establish and maintain productive relationships with participating and prospective clinical study sites.
• Coordinate study-site readiness, including instrument installation, application setup, study materials, and site logistics.
• Train laboratory and technical personnel on diagnostic instruments, assays, study procedures, and applicable protocols.
• Provide hands-on, on-site support throughout clinical evaluations and troubleshoot study-related issues as needed.
• Manage the appropriate handling, tracking, storage, and disposition of investigational products and study supplies.
• Support the collection, review, and analysis of study data, including preliminary and on-site data analysis.
• Maintain accurate, complete, and high-quality clinical study documentation and site files.
• Contribute to study reports, technical documentation, white papers, and scientific publications.
• Assist with study protocols and evaluations conducted in simulated customer or laboratory environments when needed.
• Collaborate cross-functionally with clinical, scientific, technical, and product teams throughout study execution.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, Medical Technology/Medical Laboratory Science, or a related scientific discipline.
• Clinical Research Associate (CRA) certification or equivalent qualification.
• Minimum of 2 years of clinical research experience coordinating or monitoring IVD clinical trials or evaluations.
• At least 2 years of experience in a clinical laboratory, diagnostic company, product/technical support function, or diagnostic product development environment.
• Technical understanding of automated clinical laboratory systems, diagnostic instrumentation, and assays.
• Experience with statistical and data-analysis tools used for method evaluation, analytical performance, and clinical study data.
• Proficiency with Microsoft Office and related clinical/data-analysis applications.
• Strong ability to understand and communicate complex scientific, clinical, and technical concepts.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to work independently while coordinating activities across clinical sites and internal teams.

Preferred Experience

• Previous experience supporting Hemostasis or Blood Gas instrumentation and assays.
• Experience working directly with hospital laboratories or other clinical diagnostic testing environments.
• Hands-on experience with instrument installation, applications training, troubleshooting, or technical support.
• Experience supporting studies across multiple sites or international clinical evaluations.

Travel

This is a highly field-oriented position requiring at least 50% travel, including both domestic and international travel. Candidates should be comfortable with a flexible schedule based on clinical-site activities and study timelines.