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.
Responsibilities
- 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
Skills
- 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
- 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
- Experience working on catheter-based cardiovascular medical device studies strongly preferred
Benefits
- Bonus opportunities
- Equity
- Company-sponsored benefits
Company Overview
T45 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/.