Senior Clinical Research Associate VahatiCor

Title: Senior Clinical Research Associate - VahatiCor

Status: Full-time Exempt

Reports to: Director of Clinical Affairs VahatiCor

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 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.

Responsibilities

Site Monitoring & Study Execution

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.

Documentation & Quality

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.

Cross-Functional Collaboration

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.

Required Experience & Qualifications

Bachelors 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.

Eligibility

Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas or permanent residency (PERM) applications.

Location and Compensation

This role is based in Santa Clara CA and is open to candidates living within a reasonable commuting distance of our office. At this time we are not considering applicants who would need to relocate either within or outside of California. There is no relocation package available.

VahatiCor is committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses equity and benefits as part of the total rewards package.

Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience skills qualifications and abilities relevant to the role as well as the geographic location of the individual hired.

The anticipated salary range of this position is $133000 - $179000 based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.

Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range based on these considerations.

Equal Opportunity Statement

VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications merit and business needs. We do not discriminate based on race color religion sex sexual orientation gender identity national origin disability veteran status or any other protected characteristic.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email

Required Experience:

Senior IC