Sr Clinical Research Associate

TITLE: Senior Clinical Research Associate

Why TRUVIC?

Do you want to make a true impact? TRUVIC is redefining vascular thrombus management. As part of our team, you’ll be developing breakthroughs that will benefit patients across the care spectrum. Every day, the technologies that we advance at TRUVIC directly impact patients’ lives. Our team has patients and providers at the center of our designs and work. When you join our team, this can be your focus as well.

What You’ll Do:

As a Senior Clinical Research Associate, you will proactively monitor the conduct and progress of clinical studies to ensure compliance with the study protocol, standard operating procedures, good clinical practices, and applicable regulatory requirements. In addition, the candidate will lead the clinical site support throughout the lifecycle of the project and liaise with internal team members and external clinical sites, investigators, consultants, and vendors involved in study execution.

• Lead clinical research activities to ensure successful execution of clinical studies
• Oversee the conduct of the clinical studies at participating clinical sites to ensure compliance to the protocol, standard procedures, good clinical practice, and regulatory requirements
• Conduct monitoring visits and co-monitoring visits to evaluate external CRA
• Identify, address, and resolve issues that arise with participating clinical sites.
• Collaborate with clinical team and cross functional teams and coordinate shipment, tracking and accountability of the investigational device
• Assist in project planning, study financial planning and responsible for invoice tracking/reconciliation, issuing payments and vendor management
• Prepare participating clinical sites for potential inspections

What You’ll Bring:

• Bachelor’s degree in related field and 5+ years of experience in medical device industry and clinical research or advanced degrees (Master’s, MD or PhD) with 2 years of experience in a relate field or equivalent experience
• Experience in IDE studies strongly desired
• Extensive knowledge of FDA requirements, ICH GCP, other standards as well as medical terminology
• Extensive knowledge of hospital, and health care environments
• Experience interacting with physicians and research staff
• Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Join us! Truvic

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