Clinical Research Associate III

🔥 59 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.

📋 Description

• Independently manage 10–15 investigational sites from start-up through close-out • Perform SIV, IMV, and COV monitoring visits according to the Monitoring Plan • Ensure compliance with protocols, Monitoring Plans, SOPs, ISO 14155, FDA requirements, and local regulations • Conduct SDV/SDR, informed consent review, and AE/SAE oversight • Own assigned investigator sites and ensure successful site management and performance • Build and maintain relationships with Principal Investigators and site staff • Train, guide, and support site personnel • Manage queries, provide updates, and drive issue resolution • Ensure data quality, timely query resolution, and site compliance • Identify risks and support audit and inspection readiness • Collaborate with Data Management, Clinical, and Project Management teams • Attend Investigator and/or Coordinator meetings • Mentor junior CRAs and provide guidance on problem-solving and best practices • Support training initiatives and review work to promote team development and consistency • Provide support to upper management through study updates, escalations, and operational decision-making

🎯 Requirements

• 5+ years of CRA experience • Strong medical device experience • Cardiovascular/TEVAR medical device experience preferred • Solid understanding of GCP and FDA regulatory requirements • Ability to work independently and effectively multitask, prioritizing competing activities across multiple sites and study demands • Ability to travel 50–75% of the time • Ability to manage 10–15 investigational sites from start-up through close-out • Knowledge of ISO 14155, FDA, and local requirements • Experience with SIV, IMV, and COV monitoring visits • Experience with SDV/SDR, informed consent review, and AE/SAE oversight

🏖️ Benefits

• 50–75% travel requirement is stated, but no specific benefit or compensation extras are offered in the posting

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