Sr. Clinical Research Associate - VahatiCor at T45 Labs

, , United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

153000.0

Posted On

13 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Activation, Study Startup, Site Management, Clinical Trial Execution, Patient Enrollment, Clinical Monitoring, GCP, FDA Regulations, Cardiovascular Medical Devices, Site Qualification, Relationship Building, Problem Solving, Protocol Adherence, Regulatory Documentation, Clinical Operations, Cross-functional Collaboration

Industry

Medical Equipment Manufacturing

Description

Title: Sr. Clinical Research Associate – VahatiCor Status: Full-time, Exempt Reports to: Sr. Clinical Program Manager 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 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. Required Experience & 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. Why Work for VahatiCor? ▪ 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. Why Work for VahatiCor? ▪ 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 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.

Responsibilities

The Sr. CRA is responsible for owning site activation, startup, and management to drive enrollment and protocol execution for cardiovascular clinical studies. This includes conducting monitoring visits, training site personnel, and serving as the primary operational partner to clinical sites.