Note: The job is a remote job and is open to candidates in USA. VahatiCor is a medical device company developing breakthrough cardiovascular technologies. They are seeking a Sr. Clinical Research Associate to manage site activation, study startup, site management, and enrollment performance for cardiovascular clinical studies.

Responsibilities

• Lead site qualification, feasibility, and readiness activities for assigned clinical trial sites
• Own site startup and activation activities, including collection and review of essential regulatory and startup documentation
• Ensure investigators, study coordinators, and site personnel are prepared to enroll patients efficiently and compliantly
• Partner with the Clinical Trials Manager and study leadership on site contracting and budgeting activities and ensure timely site activation
• Track startup milestones and proactively identify and resolve activation barriers
• Serve as the primary operational contact for assigned clinical trial sites
• Build and maintain strong relationships with investigators, coordinators, and site personnel
• Drive patient screening and enrollment activities to achieve study recruitment goals
• Own site performance across assigned sites and implement actions to improve enrollment, protocol adherence, and study execution
• Partner with sites to address operational challenges and maintain study momentum
• Conduct site initiation visits and provide study-specific training to investigators and site personnel
• Deliver ongoing site education throughout study execution
• Ensure study activities are conducted in accordance with the protocol, GCP, FDA regulations, and company procedures
• Participate in investigator meetings, study team meetings, and site training activities
• Conduct monitoring activities as required to ensure study quality, compliance, and protocol adherence
• Review site documentation and study records for completeness and accuracy
• Identify protocol deviations, compliance concerns, and operational risks and escalate appropriately
• Ensure site documentation is complete, accurate, maintained in accordance with study requirements, and inspection-ready at all times
• Partner closely with the Clinical Trials Manager, Sr. Clinical Program Manager, Clinical Affairs, Regulatory, Quality, and Data Management teams
• Communicate site feedback, enrollment trends, operational challenges, and emerging risks to study leadership
• Contribute to continuous improvement of site activation, enrollment, and study execution processes

Skills

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline
• 7+ years of clinical research experience within the medical device industry
• Demonstrated experience owning site startup, activation, enrollment, and clinical trial execution activities
• Experience owning site qualification, initiation, monitoring, and site management activities
• Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations
• Strong written and verbal communication skills
• Strong organizational, relationship-building, and problem-solving skills
• Ability and willingness to travel up to 60% to conduct site startup, activation, training, monitoring, and study execution activities
• Thrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to success
• Experience working on catheter-based cardiovascular medical device studies strongly preferred

Benefits

• Bonus opportunities
• Equity
• Company-sponsored benefits

Company Overview