Clinical Study Associate Jobs in Gilbert, AZ (NOW HIRING)

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 Associate Medical Director/ Medical Director/ Senior Medical Director, Imaging is primarily responsible for managing the development of essential documents and processes related to image analysis, reader training and reader performance for clinical trials. The Associate Medical Director/ Medical Director/ Senior Medical Director, Imaging may interact with external clients, internal team members, Key Opinion Leaders (KOLs), and Physician Consultant/Contracted reviewers regarding the development of required clinical trial documents. The Associate Medical Director/ Medical Director/ Senior Medical Director, Imaging will be expected to support delivery of IE’s central reader training with regards to study procedures and protocol criteria; and ensuring adherence to Protocol requirements and quality management practices, as applicable.

RESPONSIBILITIES

• Perform and/or assist with medical/scientific project deliverables for imaging studies in clinical trials in accordance with the project scope of work and within sponsor required timelines including but not limited to:
  • Review Protocols
  • Imaging Review Charters
  • Imaging Manuals and Image QC Guidelines
  • Trial Configuration Specification
  • Reader Rules and Medical QC Guidelines
• Review and/or write medical and scientific training materials and training modules
• Perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists
• Review Radiology and Medical BICR data to ensure central reader competence and adherence to study requirements
• Review development of reader performance metrics plans and review reader performance data
• Design, review, and approve study-related reports (i.e. interim or final reports)
• Provide support to internal IE staff on the QC of images and BICR reads based on expert radiological and criteria skill
• Develop expertise, maintain knowledge and train others in the use of IE’s image analysis platforms as it relates to the performance of BICR reads
• Develop educational and training material for the development internal IE staff, to include, but not limited to various response criteria
• Provide educational training for all of IE staff, as required
• Collaborate with internal project teams to support sponsor specified project scope of work as required
• Assist with projects related to IE’s research and technology development studies as requested
• Perform other duties as assigned

EDUCATION AND EXPERIENCE

• MD / radiology degree preferred
• Minimum of 3 years of experience in medical imaging/or
• Minimum of 3 years of experience in clinical research or pharmaceutical industry/or
• Preferably 3 years within an imaging core lab (an imaging CRO) with oncology experience

RESPONSIBILITIES

• Train new hires for associate medical director and/or medical director.
• Support business development activities as needed
• Oversee, performs and/or assist with medical/scientific project deliverables for imaging studies in clinical trials in accordance with the project scope of work and within sponsor required timelines including but not limited to:
  • Review Protocols
  • Imaging Review Charters
  • Imaging Manuals and Image QC Guidelines
  • Trial Configuration Specification
  • Reader Rules and Medical QC Guidelines
• Review and/or write medical and scientific training materials and training modules
• Perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists
• Review Radiology and Medical BICR data to ensure central reader competence and adherence to study requirements
• Review development of reader performance metrics plans and review reader performance data
• Design, review, and approve study-related (i.e. interim or final reports)
• Provide support to internal IE staff on the QC of images and BICR reads based on expert radiological and criteria skill
• Develop expertise, maintain knowledge and train others in the use of IE’s image analysis platforms as it relates to the performance of BICR reads
• Develop educational and training material for the development internal IE staff, to include, but not limited to various response criteria
• Provide educational training to all IE staff, as required
• Collaborate with internal project teams to support sponsor specified project scope of work as required
• Assist with projects related to IE’s research and technology development studies as requested
• Perform other duties as assigned

EDUCATION AND EXPERIENCE

• MD / radiology degree preferred
• Minimum of 3 years of experience in medical imaging/or
• Minimum of 3 years of experience in clinical research or pharmaceutical industry/or
• Preferably 3 years within an imaging core lab (an imaging CRO) with oncology experience

RESPONSIBILITIES

• Support scientific and medical thought leadership and strategic growth
• Oversee the training of all medical directors
• Support business development activities, as needed
• Oversee, performs and/or assist with medical/scientific project deliverables for imaging studies in clinical trials in accordance with the project scope of work and within sponsor required timelines including but not limited to:
  • Review Protocols
  • Imaging Review Charters
  • Imaging Manuals and Image QC Guidelines
  • Trial Configuration Specification
  • Reader Rules and Medical QC Guidelines
• Review and/or write medical and scientific training materials and training modules
• Perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists
• Review Radiology and Medical BICR data to ensure central reader competence and adherence to study requirements
• Review development of reader performance metrics plans and review reader performance data
• Design, review, and approve study-related reports (i.e. interim or final reports)
• Provide support to internal IE staff on the QC of images and BICR reads based on expert radiological and criteria skill
• Develop expertise, maintain knowledge and train others in the use of IE’s image analysis platforms as it relates to the performance of BICR reads
• Develop educational and training material for the development of internal IE staff to include, but not limited to various response criteria
• Provide educational trainings to all IE staff, as required
• Collaborate with internal project teams to support sponsor specified project scope of work as required
• Assist with projects related to IE’s research and technology development studies as requested
• Perform other duties as assigned

EDUCATION AND EXPERIENCE

• MD / radiology degree preferred
• Minimum of 7 years of experience in medical imaging/or
• Minimum of 7 years of experience in clinical research or pharmaceutical industry/or
• Preferably 7 years within an imaging core lab (an imaging CRO) with oncology experience

SKILLS

• Expert knowledge of radiologic imaging modalities and assessments related to efficacy endpoints common to clinical trials with emphasis in oncology
• Expert knowledge of FDA Guidance documents related to imaging and knowledge of the regulated environment applicable to an imaging core lab and the pharmaceutical drug development industry
• Ability to understand technical research protocols
• Ability to work in strict compliance with all procedures, rules, and regulations
• Must have superior attention to detail and excellent oral and written communication skills
• Coaching, mentoring, and development
• Ability to think strategically and tactically and develop plans accordingly
• Hands-service-oriented approach, flexible and proactive towards adapting to clients’ needs
• Ability to manage project activities with diverse groups and individuals
• Ability to excel in a team-oriented, fast paced environment
• Must have the ability to multitask and work under pressure
• Must have strong time management and organizational skills. Prioritizing workload according to the changing needs of the day-to-day business is critical
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Self-motivated and able to grasp new concepts quickly
• Proficiency in MS Office and internet applications

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 Caring Endpoints https://caringendpoints.org/
• 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
• 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: 10-20% travel (Domestic and International)