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Sr. Clinical Research Associate

$100k - $130k

Selby Jennings

Senior CRAUSA (remote)$100,000 - $130,000If you are interested in applying for this job, please make sure you meet the following requirements as listed below.Job DescriptionEPM 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 & ResponsibilitiesLead 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.QualificationsBachelor'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. xhyhwjd Excellent communication, organization, and relationship-building skills.Ability to travel approximately 40%.BenefitsCompetitive base salaryAnnual bonus opportunityEquity participationComprehensive medical, dental, and vision coverage401(k) retirement plan with company offeringsGenerous PTO and company holidaysFlexible work environmentProfessional development opportunitiesHigh-growth company with significant career advancement potential

Vacancy posted 13 hours ago
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