Sr. Clinical Research Associate - VahatiCor

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.

Qualifications

• 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.
• Experience working on catheter-based cardiovascular medical device studies strongly preferred.
• 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.