Senior Clinical Research Associate - VahatiCor
About The Position
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 Senior Clinical Research Associate will provide advanced monitoring oversight, site engagement, documentation review, and inspection-readiness support across all phases of our cardiovascular clinical studies. This role requires hands-on execution, strong judgment, and the ability to operate effectively in a fast-moving environment. Experience in medtech is imperative.
Requirements
- Bachelor’s degree in the life sciences or a related field.
- Minimum 5+ years of experience as a CRA, with significant experience in medtech; cardiovascular device experience strongly preferred.
- Demonstrated success monitoring early-stage and/or Class III device trials.
- Strong knowledge of FDA regulations, ICH/GCP, and clinical research operations.
- Excellent communication, site management, and documentation skills.
- Ability to travel up to approximately 50%.
- Comfortable working in a dynamic, fast-paced environment.
Responsibilities
- Lead monitoring activities to ensure compliance with protocols, SOPs, FDA regulations, and ICH/GCP guidelines.
- Conduct qualification, initiation, interim, and close-out visits (in-person and remote).
- Perform source data verification, eCRF review, and oversee query resolution.
- Maintain strong relationships with investigational sites to support enrollment, data quality, and overall study performance.
- Provide timely issue identification, escalation, and follow-up.
- Review and support development of study materials such as monitoring plans, site tools, and trackers.
- Ensure TMF quality, accuracy, and completeness.
- Contribute to vendor oversight activities and quality checks.
- Support audit and inspection-readiness processes.
- Work closely with CTMs, data management, clinical leadership, and vendors.
- Support investigational product tracking and reconciliation.
- Participate in study team meetings and provide operational insight.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
