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

Vahati Cor 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 Vahati Cor’scardiovascular 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 insponsor-side medical device clinical research, clinical operations,site management, andearly-stage medical device clinical trials.

• 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.

• 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.

• 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.

• 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 elevate appropriately.
• Ensure site documentation is complete, accurate, maintained in accordance with study requirements, and inspection-ready at all times.

• 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.

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
• 7+ years of clinical research experience supporting medical device clinical trials.
• Sponsor-side medical device clinical research experience is required. Candidates whose experience is primarily CRO-based without direct sponsor-side medical device experience will not meet the requirements for this role.
• Prior clinical operations experience within an early-stage medical device company is required.
• Demonstrated experience owning clinical study startup, site activation, patient enrollment,and clinical trial execution activities.
• Experience owning site qualification,Site Initiation Visits (SIVs), clinical trial monitoring,and site management activities.
• Cardiovascular medical device clinical trial experience is highly valued, particularly experience with catheter-based or other interventional cardiovascular technologies.
• Demonstrated understanding ofGood Clinical Practice (GCP), FDA medical device regulations,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…