Senior Clinical Research Associate

🕒 June 24

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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, 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. • 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. • 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. • 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. • 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.

🎯 Requirements

• 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.