Leading Innovation in MedTech.
Senior Clinical Research Associate
Location
United States
Posted
1 day ago
Salary
$113K - $153K / year
Seniority
Senior
Job Description
Senior Clinical Research Associate
T45 Labs
• 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.
Job 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.
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