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 Clinical Research Associate will provide monitoring support, site engagement, documentation review, and operational assistance across all phases of our cardiovascular clinical studies. This role requires strong site management skills, attention to detail, and the ability to work effectively in a fast-moving environment. Experience in medtech is imperative.
Requirements
- Bachelor’s degree in the life sciences or a related field.
- Minimum 2–4 years of experience as a CRA within the medtech industry; cardiovascular device experience preferred.
- Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations.
- Strong written and verbal communication skills.
- Ability to travel up to approximately 50%.
- Comfortable working in a dynamic, fast-paced environment.
- Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship.
Nice To Haves
- cardiovascular device experience
Responsibilities
- Conduct routine monitoring activities to ensure compliance with protocols, SOPs, FDA regulations, and ICH/GCP guidelines.
- Support qualification, initiation, interim, and close-out visits (in-person and remote).
- Perform source data verification, eCRF review, and assist with query resolution.
- Build and maintain strong relationships with investigational sites to support enrollment and data quality.
- Identify site-related issues and escalate appropriately.
- Assist with the development and review of study documents, tools, and trackers.
- Ensure timely and accurate TMF filing.
- Support vendor oversight activities and quality checks.
- Participate in audit and inspection-readiness activities.
- Work closely with CTMs, CRAs, data management, and other clinical team members.
- Support investigational product tracking and reconciliation activities.
- Participate in team meetings and contribute to operational problem-solving.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
