Remote IVD Clinical Research Associate

Piper Companies; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

PTO

Paid holidays

Sick leave

Job summary

Piper Companies is seeking an IVD CRA to support clinical studies and site management activities in the diagnostics and medical device industry. The ideal candidate will have expertise in in vitro diagnostics, site monitoring, regulatory compliance, and trial execution.

This role requires travel to sites 8-10 days per week and collaboration with cross-functional teams. Responsibilities include monitoring visits, data review, CAPA tracking, and ensuring adherence to GCP and regulatory standards.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3+ years in clinical research, supporting IVD/diagnostic or medical device studies.
• Strong knowledge of FDA regulations and ICH-GCP guidelines.
• Experience with onsite and remote monitoring.
• Excellent written and verbal communication skills.

Responsibilities

• Conduct site qualification, initiation, monitoring, and closeout visits for IVD studies.
• Ensure sites comply with study protocols, GCP, and regulatory requirements.
• Review source data and case report forms for accuracy.
• Identify protocol deviations and implement CAPAs.
• Collaborate with investigators, coordinators, and sponsors to meet study objectives.
• Monitor patient enrollment and study progress across sites.
• Prepare monitoring visit reports and maintain trial documentation.
• Support audit and inspection readiness throughout the study lifecycle.

Skills

Effective communication

Clinical monitoring

Data review

Regulatory knowledge

Travel readiness

Education

Bachelor's degree in Life Sciences or related field

Tools

EDC systems

CTMS

Job description

Piper Companies is seeking an IVD CRA to support clinical studies and site management activities in the diagnostics and medical device industry. The ideal candidate will have expertise in in vitro diagnostics, site monitoring, regulatory compliance, and trial execution.

This role requires travel to sites 8-10 days per week and collaboration with cross-functional teams. Responsibilities include monitoring visits, data review, CAPA tracking, and ensuring adherence to GCP and regulatory standards.