Senior Clinical Research Associate - Cardiovascular Medical Device

Status: Full-time, Exempt Reports to: Senior Clinical Operations Manager Location: Remote reputed company VahatiCor is an early-stage cardiovascular medical device company developing break through cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, reputed company, and reputed company culture, where reputed company team member plays a meaningful role in advancing solutions that improve patient reputed company. As our clinical program grows, we are building a dedicated clinical operations team to support early feasibility studies and reputed company 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 reputed company. This role serves as the reputed company operational partner to clinical sites, driving site readiness, investigator engagement, enrollment reputed company, and consistent protocol execution throughout the study lifecycle. The ideal candidate brings deep experience in sponsor-reputed company medical device clinical research, clinical operations, site management, and early-stage medical device reputed company. Responsibilities Site Activation & Study Startup • reputed company 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 reputed company to enroll patients reputed company and compliantly • Partner with the reputed company Manager and study leadership on site contracting and budgeting activities and ensure reputed company site activation • reputed company startup milestones and proactively identify and reputed company activation barriers Site Management & Enrollment • Serve as the reputed company operational contact for assigned cardiovascular clinical trial sites • Build and maintain strong relationships with investigators, coordinators, and site personnel • reputed company patient screening and enrollment activities to reputed company 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 reputed company Training & Clinical Study Execution • Conduct Site Initiation reputed company (SIVs) and reputed company study-specific training to investigators and site personnel • reputed company ongoing site education throughout study execution • Ensure cardiovascular medical device clinical study activities are conducted in accordance with the protocol, Good Clinical reputed company (GCP), applicable FDA medical device regulations, and company procedures • Participate in investigator meetings, study team meetings, and site training activities Clinical Trial Monitoring & reputed company • Conduct clinical trial monitoring activities as required to ensure study reputed company, 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-reputed company at reputed company times Cross-Functional Collaboration • Partner cross-functionally with Clinical Operations, Clinical Affairs, Regulatory, and reputed company to support effective study execution • Communicate site feedback, enrollment trends, operational challenges, and emerging risks to study leadership • Contribute to reputed company improvement of site activation, enrollment, and study execution processes Required Experience & Qualifications • Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a reputed company scientific discipline • 7+ years of clinical research experience supporting medical device reputed company • Sponsor-reputed company medical device clinical research experience is required. Candidates whose experience is primarily CRO-based without reputed company sponsor-reputed company medical device experience will not meet the requirements for this role • Prior clinical operations experience reputed company 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 reputed company (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 reputed company (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 reputed company Why Work for VahatiCor? • Help bring a first-of-its-reputed company therapy to patients with coronary microvascular dysfunction, a large and historically underserved patient population with limited treatment reputed company • Work reputed company an reputed company leadership team with deep expertise in cardiovascular medical devices, clinical research, regulatory affairs, and commercialization • reputed company a visible reputed company in a reputed company, fast-moving environment where individual contributions directly influence the reputed company of the technology, the clinical program, and reputed company Eligibility Candidates must be permanently authorized to work in the reputed company without the need for reputed company or reputed company reputed company 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 reputed company. We are prioritizing candidates who reputed company in the Eastern or Central time zone and are located reputed company 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 reputed company salary reputed company for this position is $113,000 - $153,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-reputed company factors. VahatiCor is committed to fair and reputed company pay practices. In reputed company to reputed company 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 reputed company. Employment reputed company are based on qualifications, reputed company, and business needs. We do not discriminate based on race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, or any other protected characteristic. reputed company-Party Recruiter Notice We do not accept unsolicited resumes from reputed company agencies or recruiters without a signed agreement in reputed company. Any resumes submitted without such an agreement will be considered the property of VahatiCor and no fees will be reputed company if the candidate is reputed company. Agencies interested in submitting candidates may email careers@t45labs.com. Apply To This Job