Senior Clinical Research Associate - Cardiovascular Medical Device

Senior Clinical Research Associate - Cardiovascular Medical Device

Status: Full-time, Exempt
Reports to: Senior Clinical Operations Manager
Location: Remote
Overview

VahatiCor is an early - stage cardiovascular medical device company developing break through 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 Senior Clinical Research Associate (CRA) will own site activation, clinical study startup, site management, enrollment performance, and protocol execution across VahatiCor’s cardiovascular medical device clinical trials. 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 sponsor-side medical device clinical research, clinical operations, site management, and early-stage medical device clinical trials.
Responsibilities
Site Activation & Study Startup

- Lead site qualification, feasibility, and readiness activities for assigned car diovascular medical device clinical trial sites.

- Own clinical study startup and site 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 cardiovascular 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 & Clinical Study Execution

- Conduct Site Initiation Visits (SIVs) and provide study-specific training to investigators and site personnel.

- Deliver ongoing site education throughout study execution.

- Ensure cardiovascular medical device clinical study activities are conducted in accordance with the protocol, Good Clinical Practice (GCP), applicable FDA medical device regulations, and company procedures.

- Participate in investigator meetings, study team meetings, and site training activities.

Clinical Trial Monitoring & Quality

- Conduct clinical trial 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 cross-functionally with Clinical Operations, Clinical Affairs, Regulatory, and Quality to support effective study execution.

- 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