Sr. Clinical Research Associate - VahatiCor

Title: Sr. Clinical Research Associate – VahatiCor
Status: Full-time, Exempt
Reports to: Sr. Clinical Program Manager

Overview

VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing solutions that improve patient outcomes. As our clinical program grows, we are building a dedicated clinical operations team to support early feasibility studies and future pivotal trials.

The Sr. Clinical Research Associate will own site activation, study startup, site management, enrollment performance, and protocol execution across VahatiCor’s cardiovascular clinical studies. This role serves as the primary operational partner to clinical sites, driving site readiness, investigator engagement, enrollment success, and consistent protocol execution throughout the study lifecycle. The ideal candidate brings deep experience in clinical operations, site management, and cardiovascular medical device studies.

Responsibilities

Site Activation & Startup

▪ 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.

Site Management & Enrollment

▪ 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.

Training & Study Execution

▪ 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.

Monitoring & Quality

▪ 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.

Cross-Functional Collaboration

▪ 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.

Required Experience & 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 ada