Clinical Project 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 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 Honor Health, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/Rad Partners), 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 to work with the Operations staff, Sponsor staff, and study sites in coordinating clinical project activities. The Clinical Project Coordinator / Clinical Project Coordinator II / Lead Clinical Project Coordinator requires skill similar to a Clinical Research Coordinator (CRC) but does not have direct patient interaction.

CLINICAL PROJECT COORDINATOR
RESPONSIBILITIES
Site evaluations
Following standard operating procedures evaluate sites for capability to participate in the imaging in assigned trials
Escalate site evaluation issues to Project Manager (PM)
Schedule and coordinate site trainings
Primary contact for clinical trial site activities
Maintaining Project Tracker
Trial Master File (TMF) owner
Maintain TMF and ensure project documents are complete, current, and stored appropriately according to SOPs
Document the discrepancies are remediation plans and instruct appropriate department on the correction required
Audit preparation and readiness activities
Provide study documents for audit to the study compliance team member as required
Verify all processes and procedures to maintain compliant standards of the study
Verification of PM activities for study and read start up
Provide direction on compliance per company SOPs on to study readiness for the appropriate stage of the clinical trial
Direct PM on remediation of outstanding issues
Assist PM with other project start-up activities and throughout the life cycle of the project
Ensure timely updates to project tracker, including study enrollment
Perform User Acceptance Testing as assigned by supervisor
Tracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicable
Provide pre-processing help for CTIS tasks, such as DTF downloads to the study repository
Track, data-enter, and manage Case Report Forms (CRFs), queries, and clinical data flow
Convert clinical dossiers for reader assignments per SSPs
Report on project status to client and management; generate weekly status, site, and enrollment reports
Contact sites for query and data follow up
Schedule project meetings, generate agendas and document meeting minutes
Understand and comply with protocol guidelines and requirements of regulatory agencies
Maintain confidentiality and adhere to HIPAA regulations
Perform other duties as assigned by supervisor
EDUCATION AND EXPERIENCE
Bachelor’s degree required
Experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)
Prior experience as Clinical Research Coordinators (CRC) would be preferred for this position
Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
Has strong organizational and time management skills
Proficiency in MS Office and internet applications required

CLINICAL PROJECT COORDINATOR II
RESPONSIBILITIES
Coordinate & collaborate with PMs for the site list, updating the site contact details and granting relevant system access (AG Mednet, CTMS)
Site evaluations
Following Standard operating procedures evaluate sites for capability to participate in
the imaging in assigned trials
Escalate site evaluation issues to Project Manager (PM)
Schedule and coordinate site trainings
Act as primary contact for clinical trial site activities
Trial Master File (TMF) owner
Maintain TMF and ensure project documents are complete, current, and stored
appropriately according to SOPs
Document the discrepancies and remediation plans and instruct appropriate
department on the correction required
Responsible for audit readiness of assigned trials
Provide study documents for audit to Study Compliance member as needed
Verify all processes and procedures to maintain compliant standards of the study
Verification of PM activities for study and read start up
Provide direction on…