Clinical Data Coordinator

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^TM. 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 Clinical Data Coordinator’s primary responsibilities are conducting the processing of project data, conducting data entry into electronic data capture systems, conducting quality control review of data, generating and conducting quality control review of project reports, and resolving project issues. Other duties may include coordinating with the appropriate staff to complete work as detailed in a client’s work order, filing project related documents, effectively communicating project status with internal and external stakeholders, and assisting Compliance, IT, and CDM with any testing for validation or qualification of data collection tools or spreadsheets.

RESPONSIBILITIES

• Assist in processing radiological images received for client projects in accordance with standard operating procedures
• Enter clinical trial data into data collection tools
• Conduct quality control review of clinical trial data
• Conduct data review of CRFs, eCRFs, reports, or data listings, as applicable
• Generate, track, and close queries for images, reports, CRFs, eCRFs, as applicable
• Conduct data/image transfers, as applicable
• Monitor radiology readers for applicable on site reads
• Track conduct of DE/QC activities
• Generate and/or quality control review Diagnostic and Summary Reports
• Support data analysis activities
• Support database lock activities.
• Support study closeout and reconciliation activities
• Conduct UAT activities for data collection and transfer systems/tools
• Maintain both paper and electronic project files in accordance with standard operating procedures
• Advocate compliance with all standard operating procedures
• Contribute to generation of Study Specific Procedures (SSPs)
• Contribute to generation study specific reports
• Contribute to generation of study specific data collection tools/databases
• Assist Clinical Data Managers with any requested task
• Assist with training and monitoring of Clinical Data Assistants
• Update appropriate study team members and management with task, deliverable, and project statuses.  Coordinate efforts to ensure on time completion of high-quality deliverables to both internal and external partners and customers
• Perform other tasks as needed

EDUCATION AND EXPERIENCE

• High school diploma required; associate’s or bachelor’s degree preferred
• Data entry experience/competence required
• Working knowledge of medical terminology preferred
• Knowledge of clinical trials and/or healthcare industries preferred
• Expertise in using MS Office and internet applications required

SKILLS

• Must have great attention to detail and excellent oral and written communication skills
• Ability to excel in a team environment
• Must have the ability to multitask and work under pressure
• Must have strong time management and organizational skills. Prioritizing workload to the changing needs of the day to day business is a critical skill
• Ability to assess the importance of a phone call, email, or document and take appropriate action to involve the required parties quickly and accurately
• Work precisely according to all procedures, rules, and regulations
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Self-motivated and able to grasp new concepts quickly

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure^TM 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
• 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: 5 – 10% travel (Domestic and International)