Clinical Research Associate III

Artivion; Kennesaw (GA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Artivion, Inc. seeks a Site Monitoring & Management professional to independently oversee 10–15 investigational sites from start-up to close-out in Georgia. You will perform SIV/IMV/COV visits per the Monitoring Plan and ensure protocol/SOP/regulatory compliance (ISO 14155, FDA, local rules).

You will conduct SDV/SDR, informed consent review, AE/SAE oversight, and maintain strong PI relationships. Travel 50–75% is required to support study execution.

Formación

• 5+ years of CRA experience.
• Strong medical device experience.
• Medical device experience, cardiovascular/TEVAR preferred.
• Solid understanding of GCP and FDA regulatory requirements.

Responsabilidades

• Independently manage 10-15 investigational sites from start-up through close-out.
• Perform all monitoring visits (SIV, IMV, COV) per Monitoring Plan.
• Ensure compliance with protocol, SOPs, ISO 14155, FDA, and local requirements.
• Conduct SDV/SDR, informed consent review, and AE/SAE oversight.
• Maintain site ownership and strong PI/site staff relationships.
• Provide training and ongoing support to site personnel.
• Communicate to manage queries, updates, and issue resolution.
• Identify risks and support audit/inspection readiness.

Conocimientos

CRA experience

Medical device experience

GCP knowledge

Regulatory understanding

Descripción del empleo

Description

Position Overview:

Site Monitoring & Management

• Independently manage 10-15 investigational sites from start-up through close-out
• Perform all monitoring visits (SIV, IMV, COV) in accordance with the Monitoring Plan
• Ensure compliance with protocol, Monitoring Plan, SOPs, and applicable regulations (ISO 14155, FDA, and local requirements)
• Conduct SDV/SDR, informed consent review, and AE/SAE oversight
• Maintain full ownership of assigned investigator sites, ensuring successful site management and performance
• Build and maintain strong relationships with Principal Investigators and site staff
• Provide training, guidance, and ongoing support to site personnel
• Communicate effectively to 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 cross-functionally with Data Management, Clinical, and Project Management teams to support study execution
• Attend Investigator and/or Coordinator meetings

Team Support & Mentorship

• Share expertise and provide guidance to junior CRAs, serving as a resource for questions, problem-solving, and best practices
• Support training initiatives and review work, contributing to team development and consistency across sites
• Provide support to upper management as needed, including contributing to study updates, escalations, and operational decision-making

Qualifications:

• 5+ years of CRA experience
• Strong medical device experience
• Medical device experience, cardiovascular/TEVAR 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
• 50-75% of travel is required for this position.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.