Artivion, Inc. · 1 day ago
Lead CRA
Kennesaw, GA
Full-time
Onsite
Senior Level
5+ years expArtivion, Inc. is a medical device company headquartered in suburban Atlanta, Georgia, focused on developing solutions for cardiac and vascular surgeons. The Lead CRA will provide direction and leadership to clinical operation project teams, ensuring compliance with regulations and successful study execution.
Biotechnology
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
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
Qualification
Required
Bachelor's Degree required; degrees in health sciences strongly 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
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
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
Ability to speak and write in other languages a plus
Company
Artivion, Inc.
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pat Mackin
President & CEO
Ashley Lee
EVP, COO & CFO
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