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 1,400 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

To provide direction and leadership to multiple clinical operation project teams. This position will ensure that each study meets its intended goals and that the team conducts the clinical trial in compliance with state and federal regulations. This role emphasizes proactive quality, operational consistency, and CRA performance oversight.

Responsibilities:

• Coordinate & manage clinical monitoring activities from site start up activities to database lock.
• Provide day to day operational management of CRAs to ensure delivery against contracted scope of work.
• Ensure implementation and adherence of SOPs and study specific processes by project team.
• In concert with department leadership, assist in identifying training and development needs and opportunities for CRAs.
• Oversee the assignment of appropriate project specific training for CRAs.
• Support and/or interface with external vendors and clinical site personnel, as needed.
• Assist project management with the development of study tools, presentations, and materials for the Investigator Meetings, Site Qualification Visits and Site Initiation Visits, as required.
• Provide input in the development of clinical trial related documents including but not limited to:  protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and site initiation visit slide presentation.
• Make initial site contact, conduct evaluation visits, and subsequently establish relationships with selected trial sites to ensure study targets for recruitment, quality and costs are met.
• Assist in supporting regulatory submissions.
• Supervise shipment of study drugs and materials to the site as required.
• Conduct qualification, initiation, interim and close out visits and provide visit reports as per monitoring guidelines, as needed.
• Co-monitor study sites with assigned CRAs as required.
• Assist in the mentoring and training of departmental staff and contribute to the development of junior clinical team members.
• Assist in ensuring audit readiness, by ensuring the eTMF/TMF are up to date at all times and may be a part of the QC process for reviewing the eTMF at regular intervals.
• Maintain study specific tracking tools as needed (via Clinical Trial Management system)
• Liaise with the Safety group in the management of serious adverse events (SAEs) and SAE reports, and ensure appropriate action is taken at the trial site in accordance with the
• appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations.
• Provide trial site updates according to study specific monitoring guidelines.
• Attend Project Meetings and teleconferences and provide monitoring updates.
• Attend and present at Investigator Meetings
• Support trial sites in meeting project timelines,and proactively inform the PM and team of corrective action, as necessary.
• Assist in preparation for audits and inspections; participate in inspections and in responding to any issues identified within the timeframe specified.
• Maintain effective and meaningful communication between study site, clinical team, and client to ensure the success of the clinical trial.
• Review monitoring visit reports, metrics, protocol deviations, and follow-up items to identify trends, risks, and compliance issues; summarize findings for the study team and support development of corrective and preventative actions (CAPAs)
• Conduct routine oversight activities and targeted quality checks to ensure adequate monitoring and trial conduct
• Mentor, train, and support CRAs, including onboarding, ongoing development, and performance coaching

Qualifications:

• Bachelor’s Degree required; degrees in health sciences strongly preferred.
• 5 or more years of experience as a CRA in a CRO or medical device setting, and ability to effectively lead a project team preferred.
• Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment required.
• Ability to serve as a mentor, coach, and trainer for assigned CRAs.
• Excellent oral and written communication skills in English, including proficient presentation skills required.
• To effectively support and manage exchanges with external customers; ability to speak and write in other languages a plus.
• Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development)
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint required.
• Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.
• Ability to self-motivate, be a team player, and work independently.
• Excellent critical thinking and problem-solving skills required.