Clinical Project Coordinator / Clinical Project Coordinator II / Senior 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 Cure. 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

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 and remediation plans and instruct appropriate department on the correction required Audit preparation activities Provide study documents for audit to Study Compliance 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 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 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 presentations 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 and Image Reconciliation 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 Perform Image reconciliation as assigned by supervisor 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 Minimum 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 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

SENIOR CLINICAL PROJECT COORDINATOR

RESPONSIBILITIES

Provides onboarding training to new CPC personnel and ongoing specific project training as needed Schedules, delegates, and controls daily CPC work assignments Has oversight and assists in the coordination of CPC daily workflow as directed by department management Identifies and escalates, as appropriate, all issues including but not limited to personnel issues to department management Works closely with managers and assists them with various ongoing process improvement activities Ensure and assist department management with ongoing project progress reports while maintaining operational compliance Facilitates team meetings to communicate departmental goals and deadlines 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 Responsible for audit readiness of assigned trials 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 and Image Reconciliation 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 Perform Image reconciliation as assigned by supervisor 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 and minimum of 2 years of relevant CPC experience is required Minimum of 4 years 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 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 Experience managing global Phase III clinical trials with imaging components required

SKILLS

Proficiency in MS Office and internet applications Service oriented approach, flexible, and proactive toward adapting to client needs Ability to manage project activities with diverse groups and individuals with little supervision Must have superior attention to detail and excellent oral and written communication skills Must have the ability to work independently, multitask, and meet critical timelines under pressure Must have strong time management and organization skills Self-driven, ability to get the job done with little supervision, can‑do positive attitude Ability to excel in a team environment Ability to work in strict compliance with all procedures, rules, and regulations Maintain strict confidentiality of sensitive data, records, files, conversations, etc. Must be self‑motivated and able to grasp new concepts quickly Ability to prioritize workload to the changing needs of the day‑to‑day business Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

Passion to Connect Imaging to the Cure 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 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

Travel: 5-10% (domestic and/or international) #J-18808-Ljbffr Imperatrix Datum Solutions Corporation