StimCardio Medical · 1 month ago
Senior Clinical Research Associate (CRA)
United States
Full-time
Remote
Senior Level
5+ years expStimCardio Medical is a fast-growing medical device company developing a breakthrough non-invasive therapy for atrial fibrillation. They are seeking an experienced Senior Clinical Research Associate (CRA) to support and manage multi-center clinical trials, ensuring compliance with regulations and serving as a liaison between sites and the sponsor team.
HealthcareMedical DeviceHealth CareHome Health Care
Responsibilities
Manage and monitor multi-center clinical trials in accordance with study protocols, GCP, SOPs, FDA regulations, and applicable regulatory requirements
Conduct site qualification, initiation, interim monitoring, and close-out visits
Ensure compliance with 21 CFR Part 812, informed consent requirements, adverse event reporting, and investigational device accountability
Review source documentation, case report forms, and site records for accuracy, completeness, and protocol compliance
Identify, document, and follow up on protocol deviations, data queries, and corrective/preventive actions
Support site personnel training on protocol procedures, investigational devices, and study requirements
Collaborate with investigators, coordinators, CROs, and internal cross-functional teams to support study execution and enrollment goals
Assist in the preparation and distribution of study-related content (e.g., newsletters, informational materials) to support ongoing communication and engagement with research teams
Assist with patient education initiatives related to investigational devices and study participation
Monitor study progress, enrollment metrics, and site performance; escalate risks and propose mitigation strategies as needed
Maintain timely and accurate monitoring reports and trial master file documentation
Support audit and inspection readiness activities
Participate in investigator meetings and study team meetings as required
Qualification
Required
Bachelor's degree in sciences, life sciences, nursing, healthcare, or related field
Minimum 5+ years of CRA or 10+ years of CRC experience in the medical device industry
Demonstrated experience managing multi-center clinical trials
Strong working knowledge of ICH-GCP guidelines
Strong working knowledge of FDA regulations and 21 CFR Part 812
Strong working knowledge of clinical trial monitoring practices
Strong working knowledge of informed consent and human subject protection requirements
Experience with electronic data capture (EDC) systems and CTMS platforms
Strong organizational, communication, and problem-solving skills
Ability to work independently in a remote environment
Willingness and ability to travel up to 50% domestically
Preferred
Experience in cardiology or neuromodulation clinical trials
Experience with wearable or connected medical device technologies
Experience supporting at-home clinical trials
Prior experience supporting IDE studies
Benefits
Competitive compensation and benefits package
Opportunity to work on innovative medical technologies that improve patient outcomes
Collaborative and mission-driven culture
Company
StimCardio Medical
StimCardio Medical (formerly CardiaCare) is a medical device company developing a non-invasive, wearable neuromodulation platform designed to support patients with atrial fibrillation.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$2MKey Investors
New York AngelsSolardis Health VenturesMedTech Innovator
2025-07-01Series A
2023-09-18Seed
2022-06-07Non Equity Assistance
Recent News
2025-02-03
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