Clinical Research Associate III

Artivion, Inc.•Kennesaw, GA

About The Position

The Clinical Research Associate III independently manages 10–15 investigational sites from study start-up through close-out. The role conducts monitoring visits in accordance with the Monitoring Plan and ensures site compliance with the protocol, Monitoring Plan, SOPs, and applicable regulations, including ISO 14155, FDA, and local requirements. Responsibilities also include source data verification and review, informed consent review, adverse event and serious adverse event oversight, data quality, timely query resolution, risk identification, and audit and inspection readiness. The CRA III owns assigned investigator sites, builds and maintains relationships with Principal Investigators and site staff, and provides site personnel with training, guidance, and ongoing support. The role communicates to manage queries, provide updates, and resolve issues; collaborates with Data Management, Clinical, and Project Management teams; and attends Investigator and/or Coordinator meetings. The position also supports team development by guiding junior CRAs, sharing best practices, supporting training initiatives, reviewing work, and assisting upper management with study updates, escalations, and operational decision-making. Travel of 50–75% is required.

Requirements

At least 5 years of CRA experience.
Strong medical device experience.
Solid understanding of GCP and FDA regulatory requirements.
Ability to work independently and multitask effectively while prioritizing competing activities across multiple sites and study demands.
Ability to travel 50–75%.

Nice To Haves

Cardiovascular/TEVAR medical device experience is preferred.

Responsibilities

Independently manage 10–15 investigational sites from start-up through close-out.
Perform SIV, IMV, and COV monitoring visits in accordance with the Monitoring Plan.
Ensure compliance with the protocol, Monitoring Plan, SOPs, and applicable regulations, including ISO 14155, FDA, and local requirements.
Conduct SDV/SDR, informed consent review, and AE/SAE oversight.
Maintain ownership of assigned investigator sites and support site management and performance.
Build and maintain relationships with Principal Investigators and site staff.
Provide training, guidance, and ongoing support to site personnel.
Manage queries, provide updates, and drive issue resolution through effective communication.
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 to support study execution.
Attend Investigator and/or Coordinator meetings.
Guide junior CRAs by sharing expertise, providing problem-solving support, and advising on best practices.
Support training initiatives and review work to contribute to team development and consistency across sites.
Support upper management with study updates, escalations, and operational decision-making as needed.