Senior Clinical Research Associate - Remote MedTech Trials

Veranex; Raleigh (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Veranex is seeking a Senior Clinical Research Associate to support our Clinical Operations team in evaluating medical devices through clinical trials. The Sr. CRA will plan, develop, and execute trials ensuring adherence to protocol, regulations, and SOPs under management supervision.

The role requires 5+ years in clinical research, experience with GCP, FDA regulations, site management, and strong communication skills. Travel up to 50% is expected for site visits and monitoring.

Qualifications

• Minimum of 5 years of directly related work experience in clinical research.
• Experience with medical device IDE trials and/or non-significant risk IDE trials.
• Ability and willingness to travel 25-50%.

Responsibilities

• Ensure investigators and coordinators comply with the study protocol, GCPs, CFRs, and IRB/EC requirements.
• Serve as primary liaison to clinical sites.
• Conduct site qualification visits, start-up activities, monitoring visits, and close-out visits; generate reports per plan.
• Contribute to protocol/CRF/study plan development and regulatory reports.
• Maintain TMF documentation and ensure data quality and integrity.

Skills

Clinical research

GCP knowledge

FDA regulations

Project management

Communication skills

Autonomy

Team collaboration

MS Office

Scientist liaison

Data integrity awareness

Education

BS or BA in a scientific discipline

Tools

EDC systems

eTMF systems

Microsoft Office Suite

Job description

Veranex is seeking a Senior Clinical Research Associate to support our Clinical Operations team in evaluating medical devices through clinical trials. The Sr. CRA will plan, develop, and execute trials ensuring adherence to protocol, regulations, and SOPs under management supervision.

The role requires 5+ years in clinical research, experience with GCP, FDA regulations, site management, and strong communication skills. Travel up to 50% is expected for site visits and monitoring.