Sr. Clinical Research Associate

Senior CRA

USA (remote)

$100,000 - $130,000

Job Description

EPM is partnered with an innovative, late-stage medical device company developing a novel energy-based platform technology with the potential to redefine treatment approaches in high-growth therapeutic markets. Backed by strong clinical momentum, public market support, and a collaborative leadership team, the organization is advancing multiple clinical programs while building the next generation of minimally invasive solutions designed to improve patient outcomes.

This is an opportunity to join a fast-paced environment where Clinical Affairs plays a highly visible role in the success of ongoing and future studies.

Roles & Responsibilities

• Lead site monitoring activities across multiple medical device clinical studies.
• Support study start-up, site initiation, enrollment, monitoring, and closeout activities.
• Review source documentation, CRFs, EDC data, device accountability records, and safety reporting documentation.
• Ensure compliance with study protocols, FDA regulations, and ICH-GCP guidelines.
• Prepare monitoring reports, follow-up letters, and study documentation within required timelines.
• Support investigator meetings, site training, and cross-functional study execution activities.
• Assist with regulatory submissions, IRB communications, and clinical study reporting.
• Monitor site performance, enrollment progress, and data quality metrics.
• Manage protocol deviations, adverse event reporting, and site action item follow-up.
• Mentor junior clinical team members and contribute to process improvements.

Qualifications

• Bachelor's degree in a scientific, clinical, or related field.
• 5+ years of clinical research experience within medical device, biotech, or life sciences.
• Minimum 3 years of independent CRA monitoring experience.
• Strong knowledge of FDA regulations, ICH-GCP, and clinical trial management processes.
• Experience with EDC, CTMS, and clinical study documentation.
• Background supporting interventional, cardiovascular, surgical, electrophysiology, imaging, or other complex device studies preferred.
• Excellent communication, organization, and relationship-building skills.
• Ability to travel approximately 40%.

Benefits

• Competitive base salary
• Annual bonus opportunity
• Equity participation
• Comprehensive medical, dental, and vision coverage
• 401(k) retirement plan with company offerings
• Generous PTO and company holidays
• Flexible work environment
• Professional development opportunities
• High-growth company with significant career advancement potential