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 CureTM. 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 (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Nuclear Medicine Imaging Specialist is primarily responsible for conducting a variety of QC/analysis procedures and providing medical writing support at a clinical trial level. This person is responsible for reviewing the imaging data received from the 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 and medical scientific affairs departments and serve as the imaging technical support for internal and external staff. The Nuclear Medicine Imaging Specialist shall interact with external clients, internal team members, Key Opinion Leaders (KOLs), and Physician Consultant/Contracted reviewers around the development of required clinical trial documents when required. The Nuclear Medicine Imaging Specialist is responsible for assisting in the delivery of IE’s central reader training, study procedures and protocol criteria when required.
RESPONSIBILITIES
- Perform technical quality review of images per trial specifications
- Perform Quantitative image analysis
- Perform Imaging data reconstruction 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 image queries to address technical issues, track those issues and ensure timely resolution
- Clinical site and imaging center support
- Creation and review of imaging site questionnaires
- Develop training materials for imaging site personnel including Data Transmittal Form, Imaging Manual, Site Training slides, and other supplemental documents as needed
- Technical training of imaging site personnel (on-site or telecon)
- Develop Image QC Checklists for all studies with Nuclear Medicine as modality and assigned studies.
- Collaborate with project internal teams to support sponsor specified project scope of work as required
- Provide medical and scientific input to the following documents as necessary/applicable.
- Project Management Plans
- Imaging Review Charters
- Reader Rules
- Image Analysis Platform
- Final Study Reports
- Clinical Case Report Forms
- Study Protocols
- Provide training to Radiologist, Oncologist, and other sub-specialty Physicians on
- Imaging Review Charters/Reader Rules
- Reader Rules
- Image Analysis Platform
- Protocol-specific assessment criteria
- Monitor/evaluate reader results to ensure compliance with protocol criteria and CRF completion requirements
- Mentor and assist in the training of internal staff
- Other duties as assigned by manager
EDUCATION AND EXPERIENCE
- Registered Nuclear Medicine Technologist
- Knowledge of PET/CT imaging systems required
- Knowledge of SPECT imaging systems preferred
- Associates or Bachelor’s degree preferred
- Minimum of 3 years’ experience as a nuclear medicine technologist 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.
- Prior Project Management duties preferred, i.e., driving timelines, deliverables and managing concurrent priorities
SKILLS
- Service oriented approach, flexible and proactive with ability to think tactically and strategically
- Must have superior attention to detail and excellent oral and written communication skills
- Self-driven, ability to develop and drive project timelines
- Must be self-motivated and able to grasp new concepts quickly
- Ability to excel in a team environment
- Must have the ability to work under pressure with multiple competing priorities
- Must have strong time management, and organizational skills
- The ability to communicate clearly, concisely, and frequently and know when to use email, schedule meetings or conduct one-on-one conversations
- Prioritizing workload to the changing needs of the day-to-day business is also a critical skill.
- Ability to work in strict compliance with all procedures, rules, and regulations
- Work precisely according to all procedures, rules, and regulations
- Proficiency in MS Office and internet applications
- Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
- Ability to motivate others and keep project teams working effectively
- Possess the skills required to keep senior leadership informed to support business making decisions
- Ability to understand technical research protocols and successfully lead within the research environment, when required
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
- Passion to Connect Imaging to the CureTM 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 more information about Caring Endpoints at 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 position, 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: Up to 10 – 15% travel (Domestic and International)