Clinical Research Associate III

Regulatory Toolkit; Kennesaw (GA); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Regulatory Jobs is seeking a seasoned Clinical Research Associate to independently manage 10–15 investigational sites from startup to close-out in the United States.

The role emphasizes monitoring visits, data quality, and cross-functional collaboration with Data Management, Clinical, and Project Management teams. Travel of 50-75% is required, with a preference for cardiovascular/TEVAR device experience.

Formación

• 5+ years of CRA experience.
• Strong medical device experience (cardiovascular/TEVAR preferred).
• Solid understanding of GCP and FDA regulatory requirements.
• Ability to work independently and multitask across multiple sites and study demands.
• Travel 50-75% is required for this position.

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, Monitoring Plan, SOPs, and regulations.
• Conduct SDV/SDR, informed consent review, and AE/SAE oversight.
• Maintain ownership of assigned sites and site performance.
• Build and maintain relationships with Principal Investigators and site staff.
• Provide training, guidance, and ongoing support to site personnel.
• Communicate effectively to manage queries and drive issue resolution.
• Ensure data quality, timely query resolution, and site compliance.
• Identify risks and support audit/inspection readiness.
• Collaborate cross-functionally with Data Management, Clinical, and PM teams.

Conocimientos

CRA experience

Medical device experience

GCP & FDA regulations

Independent work

Multitasking

Descripción del empleo

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.