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.
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
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 projectEnsure timely updates to project tracker, including study enrollmentPerform User Acceptance Testing as assigned by supervisorTracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicableProvide pre-processing help for CTIS tasks, such as DTF downloads to the study repositoryTrack, data-enter, and manage Case Report Forms (CRFs), queries, and clinical data flowConvert clinical dossiers for reader assignments per SSPsReport on project status to client and management; generate weekly status, site, and enrollment reportsContact sites for query and data follow upSchedule project meetings, generate agendas and document meeting minutesUnderstand and comply with protocol guidelines and requirements of regulatory agenciesMaintain confidentiality and adhere to HIPAA regulationsPerform other duties as assigned by supervisorEDUCATION AND EXPERIENCE
Bachelor’s degree requiredExperience 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 positionKnowledge of Good Clinical Practice (GCP), Quality Assurance / Compliance in a clinical trials setting is preferredHas strong organizational and time management skillsProficiency in MS Office and internet applications requiredCLINICAL 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 compliance per company SOPs on to study readiness for the
appropriate stage of the clinical trial
Direct PM on remediation of outstanding issues
Training and mentoring Train the new CPCs on the CPC tasks and mentor them as they are assigned to
various trials
Study Closeout activities Complete all tasks related to the study closeout by coordinating with the project team
and update PM regularly
Ensure alignment of closeout timelines and communicate effectively through the
duration of the closeout activity for the trial
Effectively communicate all clinical project related information including the planning and execution of study-related meetings and presentationsAssist PM with other project start-up activities and throughout the life cycle of the projectEnsure timely updates to project tracker, including study enrollmentPerform User Acceptance Testing and Image Reconciliation as assigned by supervisorTracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicableProvide pre-processing help for CTIS tasks, such as DTF downloads to the study repositoryTrack, data-enter and manage Case Report Forms (CRFs), queries and clinical data flowConvert clinical dossiers for reader assignments per SSPsReport on project status to client and management; generate weekly status, site, and enrollment reportsContact sites for query and data follow upPerform Image reconciliation as assigned by supervisorSchedule project meetings, generate agendas and document meeting minutesUnderstand and comply with protocol guidelines and requirements of regulatory agenciesMaintain confidentiality and adhere to HIPAA regulationsPerform other duties as assigned by supervisor
EDUCATION AND EXPERIENCE
Bachelor’s degree requiredMinimum of 1 year of 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 positionKnowledge of Good Clinical Practice (GCP), Quality Assurance / Compliance in a clinical trials setting is preferredHas strong organizational and time management skillsProficiency in MS Office and internet applications requiredSKILLS
Proficiency in MS Office and internet applicationsService-oriented approach, flexible, and proactive toward adapting to client needsAbility to manage project activities with diverse group and individuals with little supervisionMust have superior attention to detail including excellent oral and written communication skillsMust have the ability to work independently, multitask, and meet critical timelines under pressureMust have strong time management and organization skillsSelf-driven, ability to get the job done with little supervision, can-do positive attitudeAbility to excel in a team environmentAbility to work in strict compliance with all procedures, rules, and regulationsMaintain strict confidentiality of sensitive data, records, files, conversations, etc.Must be self-motivated and able to grasp new concepts quicklyAbility to prioritize workload to the changing needs of the day-to-day businessAbility to understand technical research protocols and successfully lead within the research environmentIMAGING ENDPOINTS’ TEAM CHARACTERISTICS
Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imagingStrong 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 imagingCommitment and caring for our fellow team members, their families, and the communities IE serves - see Caring EndpointsIntegrity and high ethical standards; we always do the right thingHigh intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving livesStructured, 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 everydayAccountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating successHigh standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
