Clinical Research Associate - VahatiCor at T45 Labs

Santa Clara, California, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Aug, 26

Salary

133000.0

Posted On

14 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Monitoring, Source Data Verification, eCRF Review, TMF Filing, FDA Regulations, ICH/GCP Guidelines, Site Management, Clinical Operations, Medtech Experience, Cardiovascular Device Experience, Vendor Oversight, Clinical Study Execution

Industry

Medical Equipment Manufacturing

Description

Title: 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 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. Responsibilities Site Monitoring & Study Execution · 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. Documentation & Quality · 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. Cross-Functional Collaboration · 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. Required Experience & Qualifications · 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. 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 $99,000 - $133,000 annually based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. Most candidates should expect to receive an offer in the mid-point 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 careers@t45labs.com.

Responsibilities

The CRA will conduct routine monitoring activities and site visits to ensure compliance with protocols and FDA regulations. They are also responsible for source data verification, TMF filing, and maintaining strong relationships with investigational sites.