[Remote] Scientist- MRI (Imaging Clinical Research)

Note: The job is a remote job and is open to candidates in USA. Perceptive Inc. is seeking a Scientist specializing in MRI for clinical research projects. The role involves providing scientific input on clinical trials, developing imaging guidelines, and conducting training for project teams and reviewers.

Responsibilities

• Independently author internal and external facing documents and material such as: Standardized/Harmonized imaging parameters – Image Acquisition Guidelines (e.g., develop imaging parameters for specific clinical protocols to ensure standardization of imaging techniques in multi-center trials)
• With supervision – Review and provide input to relevant project related documents such as: Project Plan, Site Operations Manual, if requested, Independent Review Charter, Image QC and processing instructions (QC Form), Reviewer Manual, if applicable, Clinical Data Transfer Instructions, if applicable
• With supervision: Create training material for and present to investigator sites, CRA and client (as needed) such as PowerPoint presentation, site guides on assessment criteria and imaging parameters
• With supervision: Create training material for and present to internal team on image acquisition parameters, quality control and image processing, e.g. image operations
• With supervision: Review requirement specifications of analysis application (including eCRF) and associated applications, and customization of relevant image viewing/analysis tools
• With supervision: Conduct User Acceptance Testing
• Review CVs of potential independent reviewers
• With supervision - prepare and conduct Independent Reviewer Trainings, including: Prepare Independent reviewer Training PowerPoint slides, Review/Edit training associated documentation, Select/Prepare training and testing cases for reviewer training, Lead training of independent reviewers on the use of imaging software, analysis applications, and implementation of the review criteria
• With supervision perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers
• Identify non-compliances and non-conformances
• Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out
• Participate in project related client meetings
• Effective and professional communication with internal and external stakeholders; act as a translator as needed
• Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation
• Actively maintain and disseminate knowledge in one or more identifiable specialisms Skills
• Provide scientific input on projects for clinical trials where medical imaging and clinical data is used to evaluate efficacy and/or safety of investigational drugs or medical devices
• Work with the project team lead on project related aspects of documents, application development with supervision
• Lead the development of image acquisition guidelines, medical documentation, preparation and conduct of external project team training, central reviewer training and reviewer quality control from a medical / scientific perspective in consultation with the relevant internal support and stakeholders
• Independently author internal and external facing documents and material such as Standardized/Harmonized imaging parameters – Image Acquisition Guidelines
• Review and provide input to relevant project related documents such as Project Plan, Site Operations Manual, Independent Review Charter, Image QC and processing instructions, Reviewer Manual, Clinical Data Transfer Instructions
• Create training material for and present to investigator sites, CRA and client
• Review requirement specifications of analysis application and associated applications, and customization of relevant image viewing/analysis tools
• Conduct User Acceptance Testing
• Review CVs of potential independent reviewers
• Prepare and conduct Independent Reviewer Trainings
• Perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers
• Identify non-compliances and non-conformances
• Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out
• Participate in project related client meetings
• Effective and professional communication with internal and external stakeholders
• Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation
• Actively maintain and disseminate knowledge in one or more identifiable specialisms
• Demonstrable ability to design and deliver training to a varied and global audience at all levels
• Demonstrable knowledge of medical terminology and practices
• Proven understanding of research methodologies and pragmatic application in a regulated environment
• Proven ability of using Microsoft Office products (includ