The Minneapolis Heart Institute Foundation® (MHIF) is seeking a Imaging Core Lab Manager to help expand and maintain a high quality, world class imaging core lab for the Minneapolis Heart Institute Foundation (MHIF). Now in its 38th 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 with a mission to improve people’s lives through the highest quality cardiovascular research and education.
In this key role, this professional will be responsible for the operations of the Core Lab while driving several projects. He/she will help further build and shape the core lab, refining training, testing, processes and procedures for expansion. Working with clients of the lab, the manager will use their expertise to facilitate a successful start to projects to include clinical trial design, image acquisition and analysis protocol development and case report form development. He/she will be responsible for ongoing activities including image transfer and storage and data quality management. With study closure, this specialist will be responsible for data cleaning and analysis, data transfer and data summary and interpretation reports.
This is a unique role for someone who likes to build new programs, is experienced in imaging core lab operations, has scientific expertise preferably in CT and MR imaging, and has operational skills to run a compliant, smooth-running lab.
CT/MR Core Lab Operations and Compliance
- Develop or refine and maintain Imaging Research Core Laboratory (IRCL) Standard Operating Procedures manual and charter to include cardiac image analysis workflow, software compliance, documentation, and associated processes related to regulatory guidelines and requirements.
- Manage all aspects of clinical trial core lab operations including:
- Development of imaging protocol (acquisition, training and analysis)
- Image transfer, receipt tracking and quality control
- Case report form development
- Site manual development
- Site qualification, training and monitoring process
- Oversee completion of data analysis and interpretation
- Regulatory submission support (as needed)
- Equipment maintenance and oversight
- Benchmark other core labs and develop plans to continue to keep the MHIF Core Lab at a progressive level as one of the best in the US.
- Develop QC/QA activities at regular time intervals. Ensure that all required QC/QA elements, regulatory and accreditation 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, accreditation requirements and regulatory standards.
- Secure technology for data storage, server activity and data archival in compliance with patient Protected Health Information regulatory requirements.
- Maintain log of records for all training and meetings within the lab structure.
- Establish and track the quality and production metrics of the lab.
Core Lab Management and Relationships
- Create and manage the budget for the core lab.
- Build and execute a revenue strategy and business plan in collaboration with Center Director.
- Manage resource allocation and assignments of imaging scholars relating to project execution, educational meetings and visitors.
- 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
- In collaboration with the Imaging Research Core Laboratory Director, develop a library of cardiac CT and Cardiac MRI imaging protocols and templates that can be used as templates for future studies.
- Contribute and collaborate as an author, and/or co-author for the manuscripts and research projects of the IRCL.
- Support imaging scholars, physician fellows, and research interns participating in research projects in the Program.
- May serve as a specialty technical consultant to the imaging team.
- Develop, manage and maintain image database and analysis.
- Provide technical expertise to optimize the dissemination of research activities.
Contract and Grant Development and Management
- Provide grant support with writing and submission material.
- Develop, review and edit contracts, in collaboration with other leadership representatives from MHIF, the Minneapolis Heart Institute, Allina and Abbott Northwestern Hospital.
- Previous experience in establishing, growing and maintaining a research core lab
- Academic and/or industry experience in research and development in the areas of cardiovascular physiology, medical imaging, algorithm development, biological modeling, preclinical/clinical research
- Masters degree with a PhD degree preferred in the areas of Biomedical engineering, Medical Physics or related disciplines of study
- Effective oral and written communication skills
- Organizational skills as they related to leadership, teamwork, time management, planning, scheduling and resource coordination.
- Proficiency with various computer software applications and exposure to DICOM and PACS as it relates to the handling, storing, printing and transmitting information in medical imaging.
To apply to join our talented 70+ person team:
Please use the link below and be prepared to attach a cover letter that explains your years of expertise involving a core lab and leading a core lab.
Date Posted: June 26, 2019
The Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.