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. For additional information about Artivion, visit our website,.
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. In addition to those leadership functions, 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.

- Working closely with cross-functional teams, including Project Management, Data Management, and Medical Writing, members of this group will lead the planning, execution, and management of complex clinical trials.

- Responsibilities include leading a group of CRA in a study, operational follow up of entire site management activity in a study included but not limited to data entry, query resolution, eligibility reviews, compliance and timely management of the study specific deadlines.

- Management of site visit needs and planning, site visits report review and approvals, training other CRAs and new team members, risk assessment, and ensuring adherence to regulatory requirements and industry standards.

- Management of the 3 rd party vendors such as CROs providing monitoring service and Flying Study Nurses or Site Coordinators.

- With a focus on study-level objectives and milestones, members of this group will drive the successful completion of clinical studies while maintaining the highest standards of quality, integrity, regulatory compliance, and patient safety.

- Foster strong relationships with investigational sites, regulatory bodies, vendors, and internal cross-functional teams to ensure effective communication, study alignment, and timely resolution of issues.

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).

- This includes providing recruiting, mentorship, coaching, guidance, onboarding and support to junior CRAs, as well as overseeing their day-to-day activities performance and professional development while fostering a culture of collaboration, excellence, and continuous learning..

- Responsibilities also encompass resource allocation, workload management, and performance evaluation of team members.

- In addition to supporting the professional development of CRAs within the team, members of this group will collaborate with senior management to develop and implement strategies to optimize team performance, ensure adherence to company policies and procedures, and drive continuous improvement initiatives within the Clinical Affairs department.

- Line Managers are also accountable for their teams’ timely submission of expense reports, accurate time reporting, on time vacation planning, timely planning of site travel according to Travel Policy, timely acknowledgment of Stan