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, www.artivion.com.

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 Standard Operating Procedures (SOPs) and completion of required training, timely completion of the compliance tools provided by the management (such as CRA scorecards.. etc.)
• In addition to Leadership duties, Lead CRAs still perform monitoring duties. While performing these duties Lead CRA responsibilities are same as CRA IV level.
• 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. (ISO 14155 GCP, MDR, EU, FDA, and/or Local Regulations.etc)
• 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.
• Communicates visit findings to site personnel.
• Completes a written letter for distribution to the Principal Investigator and appropriate site personnel for monitoring visit follow-up.
• Participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
• Provides the strategic thought to the development of the monitoring plan.
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study.
• Follows-up with site to gauge progress on any action items and assess needs to reinforce completion of those action items.
• Makes updates in applicable tracking systems.
• Creates corrective and preventive action plans and trend reports.
• Identify potential sites for research participation and perform study start-up activities.
• Train sites on proper data collection and reporting of safety-related events.
• Conduct study initiation visits (SIVs).
• Provide input into final study site selection.
• Assist in initial and ongoing site personnel training as required.
• Manage site activities during study maintenance.
• Plan and/or track study milestones.
• Overview of the safety of the patients with PI (SAE/AE Reports, etc.)
• Conduct safety/efficacy review of clinical data.
• Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site.
• Participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices. This may involve participating in audits / inspections, training sessions, and process improvements such as CAPA execution.
• Develop effective relationships with investigator site staff to ensure that key clinical metrics are met.
• Identify site needs, provide solutions to facilitate the clinical trial process.
• Be involved in site management activities.
• Close down research activities at the conclusion of the study.

Special Duties on CRA IV Level

• CRA IVs are expected to share their expertise, provide guidance, and offer practical advice to the team of CRAs in a study. This includes taking ownership of a study management activity, creating a system to follow up an improvement area at all sites, performing team meetings with the other CRAs and managing the discussion.
• By fostering a culture of collaboration and knowledge sharing, CRA IVs contribute to the professional development and success of the team.
• Assist in the supervision of clinical studies in cooperation with Data Managers, Project Managers, and other Clinical Affairs team members.
• Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools.
• Provides the strategic thought to the development of the monitoring plan.
• Attend Investigator meetings and present an applicable item in the investigator meetings.
• Creates corrective and preventive action plans and trend reports.

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.