Sr. Clinical Research Associate

EPM Scientific; United States; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus opportunity

Equity participation

Comprehensive medical, dental, and vis

401(k) retirement plan with company

Generous PTO

Flexible work environment

Job summary

EPM Scientific partners with a late-stage medical device company to advance energy-based platform technologies that aim to redefine treatment in high-growth markets. This role sits in Clinical Affairs and focuses on site monitoring across multiple device studies, study start-up, enrollment, monitoring, and closeout, ensuring adherence to protocols and FDA/ICH-GCP standards.

You will review source documents, CRFs, and safety reports, prepare monitoring reports, support investigator meetings, and

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.

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.

Skills

Communication

Organization

Relationship building

Travel readiness

Education

Bachelor's degree in a scientific, clinical, or related field

Tools

EDC

CTMS

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.

• 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%.


• 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


• High-growth company with significant career advancement potential