Clinical Research Associate III

Artivion Careers•Kennesaw, GA

12h

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 compliance with the protocol, Monitoring Plan, SOPs, and applicable regulations, including ISO 14155, FDA, and local requirements. Responsibilities include source data verification and review, informed consent review, adverse event and serious adverse event oversight, maintaining site performance and data quality, resolving queries, identifying risks, and supporting audit and inspection readiness. The CRA builds relationships with investigators and site staff, provides training and ongoing support, and collaborates with Data Management, Clinical, and Project Management teams to support study execution. The role also attends investigator and/or coordinator meetings and provides guidance and mentorship to junior CRAs, including contributing to training, work review, 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, prioritizing competing activities across multiple sites and study demands.
Willingness and ability to travel 50–75%.

Nice To Haves

Cardiovascular or TEVAR experience.

Responsibilities

Independently manage 10–15 investigational sites from start-up through close-out.
Conduct site initiation, interim monitoring, and close-out 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 source data verification and review, informed consent review, and adverse event and serious adverse event oversight.
Maintain ownership of assigned investigator sites and support successful site management and performance.
Build and maintain relationships with Principal Investigators and site staff.
Provide training, guidance, and ongoing support to site personnel.
Communicate with sites to manage queries, provide updates, and resolve issues.
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, answering questions, supporting problem-solving, and sharing 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.