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:

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Proficiency in MS Office and internet applications required
• Minimum of 2 years of experience in medical imaging required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

CLINICAL TRIAL IMAGING SPECIALIST II

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases ready for read assignment per the Standard Operating Procedure (SOP) and the Study Specific Procedures (SSP)
• Perform the project trainings for new team members and site trainings
• 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)
• Communicate with readers about assigned reads, pending reads, and/or any other concerns when needed
• Communicate to the study team regarding issues that arise during the read assignment process
• Creation and/or review of image QC checklists, imaging manuals, site evaluation questionnaires, training material for imaging site personnel, and any other site required documents
• Perform technical training of imaging site personnel (on-site or telecon)
• Perform AG Mednet user acceptance testing (UAT) and documentation for new studies and enhancement for existing studies to confirm correct study set up
• Participate in the study related client and other meetings as and when required
• Assist with operational process improvements
• Perform other duties as assigned by manager

EDUCATION AND EXPERIENCE

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred
• Proficiency in MS Office and internet applications required
• Minimum of 3 years of experience in medical imaging required
• Minimum of 2 years of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of the drug development process and clinical trials process and/or experience working in a pharmaceutical environment preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

SKILLS

• Proficiency in MS Office and internet applications
• Service-oriented approach, flexible, and proactive toward adapting to client needs
• Ability to manage project activities with diverse group and individuals with little supervision
• Must have superior attention to detail including excellent oral and written communication skills.
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints https://imagingendpoints.com/caring-endpoints/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

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)