Cardiovascular Medical Device | Clinical-Stage Innovation
An innovative and rapidly growing clinical-stage medical device organization is seeking experienced Clinical Research Associates to support a pivotal cardiovascular clinical program. This is an exciting opportunity to join a highly collaborative clinical operations team developing next-generation technologies in a fast-growing therapeutic area.
The organization is advancing a novel structural heart platform through ongoing clinical development and expanded global trial activities. These hires will play a critical role in supporting investigative sites, driving study execution, and ensuring operational excellence across clinical trial activities.
Candidates may be considered at either the CRA II or Senior CRA level depending on experience and qualifications.
Key Responsibilities
Site Management & Monitoring
- Serve as the primary point of contact for assigned investigational sites
- Conduct qualification, initiation, interim monitoring, and close-out visits
- Provide site training for investigators, coordinators, and research staff
- Ensure compliance with study protocols, GCP, SOPs, and applicable regulatory requirements
- Support site performance, enrollment progress, and subject retention efforts
Clinical Operations Support
- Support study startup activities, including IRB/EC submissions and essential document management
- Maintain inspection readiness of study documentation and eTMF systems
- Contribute to the development of study-related materials, including manuals, worksheets, and training tools
- Assist with investigational product management and clinical vendor coordination
- Participate in data review activities, query resolution, and EDC support
Cross-Functional Collaboration
- Partner closely with internal clinical operations, data management, regulatory, and quality teams
- Participate in project meetings and provide regular site and study status updates
- Identify operational risks and proactively escalate issues when appropriate
- Support audit readiness activities and clinical inspection preparation
Qualifications
Required Experience
- Minimum 5+ years of direct clinical monitoring and site management experience
- Experience managing clinical trial sites from startup through closeout
- Strong understanding of ICH-GCP, FDA, and ISO regulations
- Excellent organizational, communication, and problem-solving skills
- Ability to manage multiple priorities in a dynamic environment
- Experience working independently and collaboratively across cross-functional teams
- Proficiency with EDC systems, Microsoft Office Suite, and clinical documentation platforms
Preferred Background
- Experience within medical device and/or cardiovascular clinical trials
- Experience working within small or emerging biotech/medtech organizations
- Exposure to pivotal or post-market clinical studies
- Prior experience supporting trials without heavy CRO oversight preferred
Additional Information
- Remote opportunity with preference for candidates located in the New England region
- Travel requirements may vary and could reach approximately 50% during peak study activity
- Opportunity to join a growing organization at an exciting stage of clinical development
This position offers the chance to make a meaningful impact within a highly innovative clinical program while working alongside an experienced and collaborative team dedicated to advancing patient care through cutting-edge medical technology.
