Senior Clinical Research Associate – Cardiovascular Medical Device

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $113k - $153k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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T45 Labs

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2022

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

T45 Labs is a Silicon Valley-based developer and venture fund that builds and finances next-generation minimally invasive cardiovascular medical technologies. It incubates and funds portfolio companies working on advanced therapies and devices — including nanoparticle dual-drug-coated balloons, coronary sinus reducers, and wireless intravascular imaging — and focuses on clinical advancement, regulatory milestones, and strategic exits. The firm combines MedTech product development, commercial strategy, and capital markets experience to advance companies toward commercialization.

📋 Description

• Lead site qualification, feasibility, readiness, clinical study startup, and site activation activities • Collect and review essential regulatory and startup documentation • Prepare investigators, study coordinators, and site personnel for compliant patient enrollment • Partner on site contracting and budgeting and ensure timely site activation • Track startup milestones and resolve activation barriers • Serve as primary operational contact for assigned cardiovascular clinical trial sites • Build relationships with investigators, coordinators, and site personnel • Drive patient screening and enrollment to achieve recruitment goals • Own site performance and improve enrollment, protocol adherence, and study execution • Address operational challenges and maintain study momentum • Conduct Site Initiation Visits and provide study-specific training • Deliver ongoing site education • Ensure studies comply with protocols, GCP, FDA medical device regulations, and company procedures • Participate in investigator meetings, study team meetings, and site training • Conduct clinical trial monitoring activities • Review site documentation and study records for completeness and accuracy • Identify and escalate protocol deviations, compliance concerns, and operational risks • Maintain inspection-ready site documentation • Collaborate with Clinical Operations, Clinical Affairs, Regulatory, and Quality • Communicate site feedback, enrollment trends, challenges, and risks to study leadership • Contribute to process improvements for site activation, enrollment, and study execution

🎯 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 required • Prior clinical operations experience within an early-stage medical device company required • Experience owning clinical study startup, site activation, patient enrollment, and clinical trial execution activities • Experience with site qualification, Site Initiation Visits (SIVs), clinical trial monitoring, and site management • Cardiovascular medical device clinical trial experience highly valued, particularly catheter-based or other interventional cardiovascular technologies • 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% • Adaptability, initiative, and collaboration in a dynamic, fast-paced, early-stage medical device environment • Permanently authorized to work in the United States without current or future visa sponsorship • Reside in the Eastern or Central time zone and be within reasonable proximity to a major airport

🏖️ Benefits

• Bonus opportunities • Equity • Company-sponsored benefits • Opportunity to help bring a first-of-its-kind therapy to patients with coronary microvascular dysfunction • Work alongside an experienced leadership team • Visible impact in a collaborative, fast-moving environment