Perform analysis and processing of medical imaging data for clinical trials in compliance with study protocols and applicable regulatory agencies. Issue and resolve queries with investigator sites and academic centers to ensure follow-up on imaging-related issues. Validate and maintain a database of medical imaging data and associated results.
– Collect images and patient reports from clinical sites
– Develop and manage clinical electronic data capture database software to store images and clinical records
– Develops and performs Quality Control records data quality and conformance checks
– Sorting medical reports with digital images
– Works with Radiologists for establishing ground truth truthing images
– Prepare image collection protocols, identify clinical sites, and manage Institutional Review Board (IRB) processes or contracts to ensure receipt and approval with clinical partners
– Work with our client sites to download FFDM, DBT, CT and MRI radiologic cases; anonymize and prepare data for research and regulatory purposes
– Collect clinical case information from sites; anonymize and transcribe clinical information, assuring compliance with clinical protocols
– Maintain accurate database of all image data with associated clinical information
– Assess image data for compliance with quality requirements as defined by data collection and clinical protocols
– Report to the internal team members about the status of image collection
– Assure consistency and compliance with study/site protocol
– Help establish image acquisition protocols on the FFDM, DBT, CT and MRI scanners, or suggest improvement strategies for those as necessary
– Post-process, analyze the collected data using various software. Document and report the analysis results.
– Run custom scripts (Python, Matlab) as necessary to automate manual steps.
– Analyze the data based on research requirements (for example: find cases which have large motion artifacts; find cases that have a sagittal orientation)
– Maintain external relationships with our clients, including interfacing with sites to obtain data and keeping sites engaged.
Desired Skills and Experience
– Clear, effective and professional communication skills, written and verbal
– Demonstrated ability to manage time and multiple projects
– Ability to work quickly with meticulous attention to detail
– Experience working with medical images desired (either in a clinical or research capacity)
– Advanced computer skills (Microsoft Office, particularly Excel and Access including VBA/SQL; use of Python or Matlab a plus)
– Knowledge of FDA regulatory requirements is required.
– Knowledge of commonly-used concepts, practices, and procedures within clinical research.
Minimum Work Experience
Minimum 3-5 years of experience in clinical research or imaging related field or equivalent skills preferred. Must has radiological imaging and software engineering experience. Ability to develop database for archiving radiological images.
Bachelor’s Degree in Engineering or Computer Science and equivalent medical imaging related work experience required.