Clinical Project Coordinator / Clinical Project Coordinator II / Senior Clinical Project Coordinator

Overview

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are focused on the vision to Connect Imaging to the Cure. We advance imaging science, technology, and services to bring curative technologies to humankind and customize clinical trial imaging to optimize efficacy demonstrations. Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, MA; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India; and Shanghai, China. We are affiliated with HonorHealth and Scottsdale Medical Imaging Limited (SMIL/RadPartners) and are recognized as a leading iCRO in oncology.

Under the direction of Imaging Operations Management, this position coordinates clinical project activities with the Operations staff, Sponsor staff, and study sites. The Clinical Project Coordinator / Clinical Project Coordinator II / Lead Clinical Project Coordinator performs work similar to a Clinical Research Coordinator (CRC) but does not have direct patient interaction.

Responsibilities

• Site evaluations
• Following standard operating procedures, evaluate sites for capability to participate in imaging in assigned trials
• Escalate site evaluation issues to the Project Manager (PM)
• Schedule and coordinate site trainings
• Primary contact for clinical trial site activities
• Maintain Project Tracker
• Trial Master File (TMF) owner
• Maintain TMF and ensure project documents are complete, current, and stored according to SOPs
• Document discrepancies and remediation plans and instruct appropriate departments on corrections required
• Audit preparation activities
• Provide study documents for audit to Study Compliance as required
• Verify processes and procedures to maintain compliant standards of the study
• Verification of PM activities for study readiness
• Provide direction on compliance per company SOPs for study readiness at the appropriate stage
• 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 the 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 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 regulatory agency requirements
• 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) preferred
• Knowledge of Good Clinical Practice (GCP) and Quality Assurance/Compliance in a clinical trials setting is preferred
• Strong organizational and time management skills
• Proficiency in MS Office and internet applications required

Clinical Project Coordinator II

Responsibilities include coordinating with PMs for site lists, updating site contact details, and granting relevant system access (AG Mednet, CTMS).

• Site evaluations
• Following SOPs evaluate sites for capability to participate in imaging in assigned trials
• Escalate site evaluation issues to PM
• Schedule and coordinate site trainings
• Act as primary contact for clinical trial site activities

• Trial Master File (TMF) owner
• Maintain TMF and ensure documents are complete, current, and stored per SOPs
• Document discrepancies and remediation plans and instruct appropriate department on corrections required

• Audit readiness of assigned trials
• Provide study documents for audit to Study Compliance as needed
• Verify processes and procedures to maintain compliant standards

• Verification of PM activities for study readiness
• Provide direction on compliance per SOPs for study readiness at the appropriate stage
• Direct PM on remediation of outstanding issues

• Training and mentoring
• Train new CPCs on CPC tasks and mentor as they are assigned

• Study Closeout activities
• Complete all tasks related to the study closeout and update PM regularly
• Ensure alignment of closeout timelines and communicate effectively throughout the closeout

Communicate all clinical project information, including planning and execution of study-related meetings

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

Tracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet, as applicable

Provide pre-processing help for CTIS tasks, such as DTF downloads to the study repository

Track, data-enter, and manage CRFs, queries, and clinical data flow

Convert clinical dossiers for reader assignments per SSPs

Report 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 (Senior CPC)

• 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
• Prior experience as Clinical Research Coordinators (CRC) preferred
• Knowledge of Good Clinical Practice (GCP) and Quality Assurance/Compliance in a clinical trials setting is preferred
• 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, flexible, and client-focused
• Ability to manage project activities with diverse groups with minimal supervision
• Strong attention to detail and excellent oral and written communication
• Ability to work independently, multitask, and meet deadlines under pressure
• Strong time management and organizational skills
• Self-motivated with a can-do attitude
• Ability to excel in a team environment
• Ability to comply with all procedures, rules, and regulations
• Maintain confidentiality of sensitive data
• Ability to grasp new concepts quickly
• Ability to prioritize workload amid changing needs
• Ability to understand technical research protocols and lead within the research environment

Team Characteristics

• Passion to Connect Imaging to the Cure and improve lives through imaging
• Strong desire to be part of a dynamic, global team
• Commitment to Caring Endpoints and communities served
• Integrity and high ethical standards; doing the right thing
• High intellect and ingenuity; solving problems and improving lives
• Structured, organized, and self-motivated; detail-oriented and planning-oriented
• Accountable and communicative to meet deadlines; advancing clinical trials and helping patients
• High standard for excellence; prioritizing quality

Physical Requirements

Regular use of hands, sitting, and visual requirements; includes close vision, color vision, and focus adjustment.

Travel

Travel: 5-10% (domestic and/or international)