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Senior Clinical Research Associate (Senior CRA)
We appreciate your interest in joining our team. Your application has been received and is currently under review. If your profile matches our requirements, we will be in touch regarding the next steps.
About StimCardio
StimCardio is a fast-growing medical device company developing a breakthrough non-invasive therapy for atrial fibrillation (AFib).
Our novel wearable combines advanced cardiac monitoring with proprietary neurostimulation technology to deliver closed-loop, patient-centric AFib management.
We are a mission-driven, execution-focused team bringing meaningful innovation to patients and physicians. This is an exciting opportunity to join us at a pivotal stage and play a key role in shaping our clinical operations.
Position Overview
We are seeking an experienced and highly motivated Senior Clinical Research Associate (Senior CRA) to support and manage our multi-center clinical trials for our novel wearable technology.
The Senior CRA will be responsible for monitoring clinical study sites across the US, ensuring compliance with applicable regulations and study protocols, supporting patient education initiatives, and serving as a key liaison between investigative sites, the sponsor team.
The ideal candidate will possess strong knowledge of Good Clinical Practice (GCP), FDA regulations including 21 CFR Part 812, and clinical trial operations within the medical device industry. Experience in cardiology and wearable medical technologies is strongly preferred.
This position requires up to 50% domestic travel.
Key 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.
Qualifications
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
- FDA regulations and 21 CFR Part 812
- Clinical trial monitoring practices
- 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
Competencies
- Strong attention to detail and documentation quality
- Effective relationship-building and site management skills
- Ability to manage multiple priorities in a fast-paced environment
- Proactive issue identification and resolution
- High level of professionalism, integrity, and accountability
What We Offer
- Competitive compensation and benefits package
- Opportunity to work on innovative medical technologies that improve patient outcomes
- Collaborative and mission-driven culture
Equal Opportunity Statement
StimCardio is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status, or any other characteristic protected by law.
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Don’t See the Right Role?
We’re always interested in connecting with talented professionals. If you don’t see a position that fits your background, please send your CV to info@stimcardio.com and include a brief note describing the type of role you’re seeking.