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About the Role

VahatiCor is an early-stage cardiovascular medical device company developing breakthrough technologies. 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 VahatiCor’s cardiovascular 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.

Responsibilities

Lead site qualification, feasibility, and readiness activities for assigned cardiovascular 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 escalate 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.

Requirements

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.
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 of Good 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 startup, activation, training, monitoring, and study execution activities.
Thrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to success.
Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship.

Skills

Cardiovascular medical device clinical trial experience
Catheter-based or other interventional cardiovascular technologies
Good Clinical Practice (GCP)
FDA medical device regulations
Clinical research operations
Written communication
Verbal communication
Organizational skills
Relationship-building skills
Problem-solving skills
Adaptability
Initiative
Collaboration

Location

Remote
Eastern United States
Eastern time zone
Central time zone

Work Type

Full-time
Remote

Experience Level

Senior
7+ years of clinical research experience

Education Level

Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline

Salary/Compensations

$113,000 - $153,000

Benefits

Bonus opportunities
Equity
Company-sponsored benefits

About the Company

VahatiCor is an early-stage cardiovascular 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.
Help bring a first-of-its-kind therapy to patients with coronary microvascular dysfunction, a large and historically underserved patient population with limited treatment options.
Work alongside an experienced leadership team with deep expertise in cardiovascular medical devices, clinical research, regulatory affairs, and commercialization.
Make a visible impact in a collaborative, fast-moving environment where individual contributions directly influence the future of the technology, the clinical program, and the company.

Equal Opportunity

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.