IVD CRA

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

Job summary

Piper Companies is seeking an IVD CRA to support clinical studies and site management activities for a leading organization in diagnostics and medical devices. The IVD CRA role emphasizes site monitoring, regulatory compliance, and clinical trial execution, with travel to sites 8-10 days per week.

The ideal candidate has a Bachelor’s degree in Life Sciences or related field and 3+ years of CRAs experience, plus strong knowledge of FDA regulations and ICH-GCP.

Qualifications

• Bachelor’s degree in Life Sciences, Clinical Research, Biology, Nursing, or related field.
• 3+ years of CRAs experience supporting IVD/diagnostic/medical device studies.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial processes.
• Experience performing onsite and remote monitoring.
• Excellent communication, documentation, and relationship management skills.
• Ability to travel as needed to support clinical study sites.
• Experience with EDC and CTMS preferred.
• Strong organizational skills with the ability to manage multiple studies simultaneously.

Responsibilities

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

Skills

Clinical Research

Site Monitoring

Regulatory Compliance

Data Review

Education

Bachelor’s degree in Life Sciences/Clinical Research/ Biology/ Nursing

Tools

EDC systems

CTMS

Job description

Piper Companies is seeking an IVD CRA to support clinical studies and site management activities for a leading organization in the diagnostics and medical device industry. The IVD CRA role is ideal for an experienced clinical research professional with expertise in in vitro diagnostics, site monitoring, regulatory compliance, and clinical trial execution. The IVD CRA will play a key role in ensuring study quality, patient safety, and adherence to applicable regulations and protocols. The IVD CRA requires you to travel to sites 8-10 days per week.

Responsibilities of the IVD CRA:

• Conduct site qualification, initiation, monitoring, and closeout visits for IVD clinical studies.
• Ensure clinical trial sites comply with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Review site documentation, source data, and case report forms to ensure data accuracy and completeness.
• Identify, document, and follow up on protocol deviations and corrective action plans.
• Collaborate with investigators, study coordinators, clinical teams, and sponsors to support study objectives.
• Monitor patient enrollment, retention, and study progress across assigned sites.
• Prepare monitoring visit reports and maintain accurate trial documentation.
• Support audit and inspection readiness activities throughout the clinical study lifecycle.

Requirements of the IVD CRA:

• Bachelor's degree in Life Sciences, Clinical Research, Biology, Nursing, or a related field.
• 3+ years of Clinical Research Associate experience supporting IVD, diagnostic, medical device, or biotechnology studies.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial processes.
• Experience performing onsite and remote monitoring activities.
• Excellent communication, documentation, and relationship management skills.
• Ability to travel as needed to support clinical study sites.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferred.
• Strong organizational skills with the ability to manage multiple studies simultaneously.

Compensation for the IVD CRA:

• Salary range: $110,000 - $140,000
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.

Keywords: IVD CRA, Clinical Research Associate, In Vitro Diagnostics, IVD Clinical Trials, Medical Device Clinical Research, Site Monitoring, GCP, ICH Guidelines, FDA Regulations, Clinical Operations, Clinical Monitoring, Source Data Verification, Site Management, EDC Systems, CTMS, Diagnostic Devices, Biotechnology, Trial Master File, Regulatory Compliance, Clinical Development, Study Startup, Clinical Investigation, Patient Enrollment, Monitoring Visits, Remote Monitoring, Medical Devices

This job opens for applications on 10/09/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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