Clinical Trial Imaging Specialist / Clinical Trial Imaging Specialist II

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIURadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Management this position is responsible for conducting a variety of QC / analysis procedures and performing read assignment as per study-specific procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites / sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.

CLINICAL TRIAL IMAGING SPECIALIST

RESPONSIBILITIES :

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform imaging data reconciliation per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Complete quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases reader for read assignment per the Standard Operating Procedure (SOP)and the Study Specific Procedures (SSP)
• Prepare study dossiers to be associated with read assignment per the SOP / SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Perform technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Maintain TMF and ensure appropriate study documents are filed for audit readiness
• Assist in the training of internal staff
• Other duties as assigned by manager

EDUCATION AND EXPERIENCE :

CLINICAL TRIAL IMAGING SPECIALIST II

RESPONSIBILITIES :

EDUCATION AND EXPERIENCE

SKILLS

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel : 5 to 10% (domestic and / or international)

Skills Required

Internet Applications, Ms Office