The Minneapolis Heart Institute Foundation® (MHIF) and its Cardiovascular Imaging Research Center (CIRC) is seeking a Core Lab Operations Leader to help expand and maintain a high quality, world class imaging core lab. Now in its 39th year, MHIF is one of the leading non-profit cardiovascular research and education institutions in the country. We exist to create a world without heart disease and our mission is to improve people’s lives through the highest quality cardiovascular research and education.
In this high impact role, you will be responsible for the operations of the Core Lab and contributing to its work products. This is an opportunity to help build and shape the core lab by ensuring and monitoring training and further developing processes and procedures. Working with clients of the lab, the operations leader will facilitate project success by providing expert imaging analysis and documentation according to research protocols and core lab procedures. The operations leader will support sponsor audits, regulatory inspections and serve as an overall subject matter expert and operational liaison to internal and external clients. This role will oversee data quality control and lifecycle management including image transfer, storage, and cleaning in addition to overseeing ongoing analysis and interpretation.
This is a unique role for someone who likes to build new programs, is experienced in imaging core lab operations, has expertise preferably in CT and CMR imaging, and has operational skills to run a compliant and efficient lab.
CT/MR Core Lab Operations and Compliance
- Develop, refine, and maintain Standard Operating Procedures, core lab charter and manuals to include cardiac image analysis workflow, software compliance, documentation, and associated processes related to regulatory requirements.
- Manage all aspects of clinical trial core lab operations including:
- Development of imaging protocol (acquisition, training, and analysis) with the Scientific Director
- Image transfer, receipt tracking and quality control
- Case report form development
- Site manual development
- Site qualification, training, and monitoring process
- Conduct data analysis and interpretation
- Regulatory submission support (as needed)
- Equipment maintenance and oversight
- Partner or conduct QC/QA activities at regular time intervals according to core lab procedures and sponsor-specific requirements. Ensure that all required QC/QA elements, regulatory and sponsor standards are met.
- Ensure that proficiency-testing requirements and procedures are consistent with contemporary lab practices and guidelines. Ensure that the laboratory maintains compliance with all federal, state, and inspecting agency regulations as well as MHIF and Allina policies and procedures.
- Create an effective partnership with the Sr. Director of Regulatory and Compliance, MHIF to ensure compliance with quality assurance and regulatory standards.
- Manage technology for data storage, server activity and data archival.
- Maintain log of records for all training and meetings within the lab structure.
- Establish and track the quality and production metrics of the lab, including monthly review with Scientific Director
- Develop a library of cardiac CT and Cardiac MRI imaging protocols and templates that can be used for future studies.
Core Lab Management and Relationships
- Support imaging scholars related to project execution, technical aspects of imaging, and educational meetings.
- Foster an environment of collaboration among MHIF staff, physicians, and investigators. Collaborate with key functions, including Research Operations, Compliance, Quality and Regulatory, and Science Center leaders for an integrated program.
Technical Support and Research Contribution
- Contribute and collaborate as a co-author for abstracts, manuscripts, and research projects.
- Provide technical expertise to optimize the dissemination of research activities.
- May serve as a specialty technical consultant to the imaging team.
Contract and Grant Development and Management
- Provide grant support with writing and submission material.
- Review and edit contracts, in collaboration with other leadership representatives from MHIF, the Minneapolis Heart Institute, Allina and Abbott Northwestern Hospital.
This position formally reports to the MHIF Program Director, Valve Science Center with close interface with the Scientific Director of the Cardiovascular Imaging Research Center (CIRC). This individual collaborates with key staff within MHIF, a range of physicians from the Minneapolis Heart Institute, research scholars, and core lab customers.
- Previous experience working in a regulated research environment
- Academic, clinical and/or industry experience in research in the areas of cardiovascular physiology, medical imaging, algorithm development, biological modeling, preclinical/clinical research
- Master’s degree or related clinical training and experience in clinical imaging analysis (CT or CMR preferred).
- Effective oral and written communication skills
- High attention to details to ensure accurate imaging analysis and compliance with quality procedures
- Organizational skills as they relate to personal leadership, teamwork, time management, planning, scheduling and resource training and coordination.
- Proficiency with various computer software applications, analysis, and exposure to DICOM data sets as it relates to the handling, storing, and transmitting information in medical imaging.
- Previous experience working in an imaging core lab
- MD or PhD
Additional Comments: This job description represents the major functions of the position but is not intended to be all-inclusive.
Join our talented 80+ person team:
Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.
Date posted: July 6, 2021