Senior Lead CRA - Clinical Study Oversight

Regulatory Toolkit; Kennesaw (GA); On-site; USD 90,000 - 140,000; Full time

Job summary

Artivion, Inc. in the Atlanta area seeks a Lead CRA to head Study Specific Lead CRA duties and act as Line Manager Lead CRA. The role includes time as a site CRA, coordinating with cross-functional teams to drive trial success while maintaining high quality and patient safety.

The position requires mentoring junior CRAs, overseeing site monitoring, and ensuring adherence to SOPs, regulatory standards, and study timelines.

Qualifications

• In-depth experience in clinical research monitoring.
• Ability to work independently without supervision.
• Ability to manage 10-15 study sites (class 2-3 products).
• Knowledgeable of regulations and guidelines for clinical trials on humans.

Responsibilities

• Lead Study Specific Lead CRA duties with strategic direction for assigned studies.
• Oversee site management activities including data entry, queries, eligibility, and deadlines.
• Manage CROs, Flying Study Nurses, or Site Coordinators as 3rd party vendors.
• Train CRAs and new team members; monitor risk and ensure regulatory compliance.

Skills

Clinical research monitoring

Independent work

Site management

Regulatory compliance

Job description

Artivion, Inc. in the Atlanta area seeks a Lead CRA to head Study Specific Lead CRA duties and act as Line Manager Lead CRA. The role includes time as a site CRA, coordinating with cross-functional teams to drive trial success while maintaining high quality and patient safety.

The position requires mentoring junior CRAs, overseeing site monitoring, and ensuring adherence to SOPs, regulatory standards, and study timelines.