[Remote] Sr. Clinical Research Associate - VahatiCor

Note: The job is a remote job and is open to candidates in USA. VahatiCor is a medical device company developing breakthrough cardiovascular technologies. They are seeking a Sr. Clinical Research Associate to manage site activation, study startup, site management, and enrollment performance for cardiovascular clinical studies.ResponsibilitiesLead site qualification, feasibility, and readiness activities for assigned clinical trial sitesOwn site startup and activation activities, including collection and review of essential regulatory and startup documentationEnsure investigators, study coordinators, and site personnel are prepared to enroll patients efficiently and compliantlyPartner with the Clinical Trials Manager and study leadership on site contracting and budgeting activities and ensure timely site activationTrack startup milestones and proactively identify and resolve activation barriersServe as the primary operational contact for assigned clinical trial sitesBuild and maintain strong relationships with investigators, coordinators, and site personnelDrive patient screening and enrollment activities to achieve study recruitment goalsOwn site performance across assigned sites and implement actions to improve enrollment, protocol adherence, and study executionPartner with sites to address operational challenges and maintain study momentumConduct site initiation visits and provide study-specific training to investigators and site personnelDeliver ongoing site education throughout study executionEnsure study activities are conducted in accordance with the protocol, GCP, FDA regulations, and company proceduresParticipate in investigator meetings, study team meetings, and site training activitiesConduct monitoring activities as required to ensure study quality, compliance, and protocol adherenceReview site documentation and study records for completeness and accuracyIdentify protocol deviations, compliance concerns, and operational risks and escalate appropriatelyEnsure site documentation is complete, accurate, maintained in accordance with study requirements, and inspection-ready at all timesPartner closely with the Clinical Trials Manager, Sr. Clinical Program Manager, Clinical Affairs, Regulatory, Quality, and Data Management teamsCommunicate site feedback, enrollment trends, operational challenges, and emerging risks to study leadershipContribute to continuous improvement of site activation, enrollment, and study execution processesSkillsBachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline7+ years of clinical research experience within the medical device industryDemonstrated experience owning site startup, activation, enrollment, and clinical trial execution activitiesExperience owning site qualification, initiation, monitoring, and site management activitiesDemonstrated understanding of FDA regulations, ICH/GCP, and clinical research operationsStrong written and verbal communication skillsStrong organizational, relationship-building, and problem-solving skillsAbility and willingness to travel up to 60% to conduct site startup, activation, training, monitoring, and study execution activitiesThrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to successExperience working on catheter-based cardiovascular medical device studies strongly preferredBenefitsBonus opportunitiesEquityCompany-sponsored benefitsCompany OverviewT45 Labs is a med-tech incubator that specializes in developing minimally invasive technologies for the cardiovascular market. It was founded in 2022, and is headquartered in Santa Clara, California, USA, with a workforce of 11-50 employees. Its website is https://t45labs.com/.