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 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 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 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

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 group and individuals with little supervision
• Must have superior attention to detail including 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 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
• 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 everyday
• 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