Monitoring Oversight Lead (Lead CRA)

Monitoring Oversight Lead (Lead CRA)

Company Overview: Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America.

Position Objective: Leading CRA I-IV teams on study and/or operational line management level. Manage assigned departmental project tasks/systems in principle areas of responsibilities identified below.

Responsibilities:

• The Lead CRA will serve as a Study Specific Lead CRA and/or Line Manager Lead CRA.
• Lead CRAs are responsible as site CRAs (individual performers) approximately 30-40% of their time.
• Study Specific Lead CRA Duties: As part of the Study Level Leadership Group within the CRA 4 level, "Study Lead CRAs" will take on a pivotal role in providing strategic direction and oversight for assigned clinical studies.
• Line Manager Lead CRA Duties: As part of the Line Management Group within the CRA 4 level, individuals will assume leadership responsibilities for overseeing and managing a team of Clinical Research Associates (CRAs).
• In addition to Leadership duties, Lead CRAs still perform monitoring duties.
• Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Healthcare standards, guidelines, and policies.
• Build and maintain strong relationships with study sites, including principal investigators and site staff.
• Provide support, training, and guidance to site personnel as needed.
• Communicate effectively to address queries, provide updates, and facilitate resolution of issues.
• Serve as the primary point of contact between the sponsor, investigational sites, and other stakeholders involved in the clinical trial.
• Participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices.

Qualifications: In depth experience in clinical research monitoring, typically gained over 8 or more years. Ability to work independently without supervision of daily CRA activities. Ability to manage 10-15 study sites (class 2 - 3 products) from start-up to closure. Knowledgeable of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects.