T45 Labs

Role Description We are seeking a Field Clinical Engineer to support physicians, cath lab teams, and investigational sites throughout the execution of VahatiCor clinical studies. This role serves as a key partner to physicians and hospital teams, providing clinical and technical expertise, investigator training, procedural support, and real-world insight that helps shape both the clinical experience and future development of our technology. The ideal candidate brings hands-on experience supporting complex interventional cardiology procedures, a strong clinical and technical foundation, and a passion for working directly with physicians to introduce innovative technologies that have the potential to improve patient care. Responsibilities - Provide on-site clinical and technical support to physicians, cath lab teams, and investigational sites during complex interventional cardiology procedures, serving as a trusted resource for procedural guidance, device support, and troubleshooting. - Train physicians, nurses, and cath lab staff on proper device use, procedural workflow, and best practices. - Lead investigator training, physician education, and clinical readiness activities. - Develop and maintain trusted relationships with physicians, investigators, and study sites. - Partner closely with clinical, engineering, and product teams to communicate physician feedback, procedural insights, and opportunities for product improvement. - Contribute to clinical study execution, site engagement, enrollment support, and clinical data collection activities. - Support site initiation visits, physician onboarding, and study-related training activities. - Collaborate with cross-functional teams to support successful execution of VahatiCor clinical studies. - Travel to clinical sites to support procedures, training, and study activities. Qualifications - Bachelor’s degree in biomedical engineering, life sciences, cardiovascular technology, nursing, or a related clinical or technical field, or equivalent clinical experience. - 5+ years cardiac cath lab experience supporting regulated clinical study activities within the medical device industry. Experience in Interventional Cardiology is a plus. - Demonstrated experience providing clinical and technical support during complex interventional cardiology procedures within the cardiac catheterization laboratory. - Experience supporting Class III cardiovascular medical devices within IDE, investigational, or other pre-approval clinical studies is strongly preferred. - Experience supporting cardiovascular catheter-based technologies, invasive imaging systems, structural heart procedures, or other advanced interventional therapies is strongly preferred. - Experience introducing, evaluating, or helping drive adoption of novel cardiovascular technologies. - Experience training physicians, nurses, and clinical staff on new technologies and procedural workflows. - Knowledge of Good Clinical Practice (GCP) and experience supporting regulated clinical studies. - Strong communication skills and a demonstrated ability to build trusted relationships with physicians, investigators, and hospital teams. - Solid understanding of invasive physiology methods and measurements such as FFR and CFR. - Ability to work independently while collaborating with distributed internal teams. - Ability to travel frequently to support clinical study activities. Eligibility - Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. Location & Compensation - This is a remote position supporting clinical sites throughout the United States. - The anticipated annual base salary range for this position is $116,000 – $158,000. - Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. Why Join VahatiCor Joining VahatiCor provides the opportunity to work alongside leading physicians and clinical innovators while helping bring breakthrough cardiovascular technology into clinical practice. As a member of the Field Clinical Engineering team, you will play a key role in supporting clinical studies, shaping physician experience, influencing future product development, and helping advance technologies designed to improve patient outcomes. 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. Third-Party Recruiter Notice We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place.

Role Description The Sr. Clinical Trials Manager will lead the planning, execution, and operational oversight of clinical studies from startup through study closeout. This role serves as the study-level operational owner, accountable for timelines, budgets, vendor performance, enrollment forecasting, study metrics, risk management, and cross-functional execution. The ideal candidate brings deep experience in clinical operations leadership, study management, and cardiovascular medical device studies. Responsibilities - Study Planning & Execution - Lead operational planning and execution of clinical studies from startup through study closeout. - Own study startup strategy and maintain accountability for site activation progress across all participating sites. - Develop and maintain study timelines, milestones, and operational deliverables. - Own enrollment forecasting, study metrics, and operational reporting. - Identify operational risks and implement mitigation plans to maintain study performance. - Ensure study execution remains aligned with protocol requirements, timelines, budgets, and business objectives. - Vendor & Operational Management - Serve as the primary operational contact for CROs, vendors, consultants, and external study partners. - Manage vendor deliverables, timelines, communication, budgets, and performance. - Own study-level vendor oversight and operational accountability. - Maintain oversight of site budgets and contracts in collaboration with Clinical Affairs and study leadership. - Ensure operational activities remain aligned across vendors, sites, and internal stakeholders. - Documentation & Quality - Maintain oversight of study documentation, TMF quality, and inspection readiness activities. - Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, quality system requirements, and study plans. - Own study-level risk identification, issue escalation, and mitigation planning. - Maintain oversight of CAPA follow-up and resolution activities. - Drive resolution of study-level operational challenges. - Cross-Functional Collaboration - Partner closely with Clinical Affairs, Regulatory, Quality, Data Management, Engineering, and other internal stakeholders. - Lead study team meetings and operational reviews. - Provide regular study updates, operational insights, enrollment forecasts, and risk assessments to leadership. - Drive alignment across internal teams, vendors, and clinical sites. - Ensure consistent execution of study processes across participating sites. Qualifications - Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline. - 7+ years of experience managing clinical studies within the medical device industry. - Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred. - Demonstrated experience leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution. - Demonstrated experience managing clinical trial timelines, budgets, operational deliverables, and external vendors. - Demonstrated experience overseeing clinical studies from startup through study closeout. - Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations. - Strong leadership, communication, organizational, and problem-solving skills. - Ability and willingness to travel up to 30% based on study and business needs. - Thrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to success. Eligibility - Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. Benefits - 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. Location and Compensation This is a remote position supporting clinical sites throughout the United States. The anticipated annual base salary range for this position is $135,000 – $183,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. Equal Opportunity Statement VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Third-Party Recruiter Notice We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place.

Role Description The Sr. Clinical Research Associate will own site activation, study startup, site management, enrollment performance, and protocol execution across VahatiCor’s cardiovascular clinical studies. 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. The ideal candidate brings deep experience in clinical operations, site management, and cardiovascular medical device studies. Responsibilities - Site Activation & Startup - Lead site qualification, feasibility, and readiness activities for assigned clinical trial sites. - Own site startup and 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. - Site Management & Enrollment - Serve as the primary operational contact for assigned 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. - Training & Study Execution - Conduct site initiation visits and provide study-specific training to investigators and site personnel. - Deliver ongoing site education throughout study execution. - Ensure study activities are conducted in accordance with the protocol, GCP, FDA regulations, and company procedures. - Participate in investigator meetings, study team meetings, and site training activities. - Monitoring & Quality - Conduct 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. - Cross-Functional Collaboration - Partner closely with the Clinical Trials Manager, Sr. Clinical Program Manager, Clinical Affairs, Regulatory, Quality, and Data Management teams. - 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. Qualifications - Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline. - 7+ years of clinical research experience within the medical device industry. - Demonstrated experience owning site startup, activation, enrollment, and clinical trial execution activities. - Experience owning site qualification, initiation, monitoring, and site management activities. - Experience working on catheter-based cardiovascular medical device studies strongly preferred. - Demonstrated understanding of FDA regulations, ICH/GCP, 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. Benefits - 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. 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 is a remote position supporting clinical sites throughout the Eastern United States. - We are prioritizing candidates who reside in the Eastern or Central time zone and be located within reasonable proximity to a major airport to support travel requirements. - Travel of up to 60% is required based on study and site needs. - The anticipated annual base salary range for this position is $113,000 – $153,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. - VahatiCor is committed to fair and equitable pay practices. - In addition to base salary, the total compensation package may include bonus opportunities, equity, and company-sponsored benefits. 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.