Clinical Research Associate

Job Description

Employment Type: Contract (Contract-to-Hire potential)

Locations: Multiple openings — Northeast | Mid/Southwest | Midwest | Southeast

Job Description:

We're partnering with a private, global medical device company pioneering neurovascular solutions for stroke, aneurysms, and arteriovenous malformations. They've just received IDE approval for their first US Class III device trial and are expanding their clinical team to support site initiation and monitoring across a 35-site trial.

Key Responsibilities:

• Lead on-site and remote monitoring visits to assess protocol and regulatory adherence
• Ensure patient and site data remain audit-ready
• Build strong relationships with sponsors and site staff, providing training on protocol/regulatory requirements
• Conduct site initiation, monitoring, and close-out visits per GCP
• Review investigational product accountability, safety events, and protocol deviations
• Resolve data queries and identify trends to reduce recurring site errors
• Mentor junior team members and support SOP development
• Maintain and update monitoring templates (Monitoring Plans, Visit Reports, Follow-Up Letters, Query Logs)

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or related field
• Minimum 5 years of IDE study experience in medical devices
• Experience with Class III devices, including device deficiency management
• Proficiency in CTMS and EDC systems
• Strong organizational skills managing multiple sites/protocols

Preferred:

• Advanced degree in Life Sciences
• Neurovascular, endovascular, or cardiology trial experience

Commitment: ~4 days on-site per month (0.5 FTE), with potential to convert to FTE