Clinical Project Coordinator

SUMMARY

Imaging Endpoints (IE) is an Imaging Research and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale,Arizona, with an office in Waltham, Massachusetts and are an affiliate of HonorHealth, one of the largest healthcare systems nationally. Additionally, IE is also an affiliate of Scottsdale Medical Imaging Limited (SMIL/SDI), one of the largest private radiology groups in the U.S. We operate in over twenty countries globally and are recognized as the preeminent iCRO for complex trials, particularly within oncology.

The primary responsibility of the Clinical Project Coordinator is to work with the Operations staff, Sponsor staff, and study sites in coordinating clinical project activities. The Clinical Project Coordinator requires skills 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 the imaging in assigned trials


• Escalate site evaluation issues to Project Manager (PM)


• Schedule and coordinate site trainings


• Primary contact for clinical trial site




• Trial Master File Owner




• Maintain TMF and ensure project documents are complete, current, and stored appropriately according to SOPs


• Document needed remediated discrepancies found and instruct appropriate department on the correction required




• Responsible for audit readiness of assigned trials




• Verify all processes and procedures to maintain compliant standards of the study on a daily basis




• 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




• Perform user acceptance testing (UAT) on the clinical trial management system (CTMS) to confirm correct study set up


• Assist PM with other project start-up activities and throughout the life cycle of the project


• Process 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


• Convert clinical dossiers for reader assignments per SSPs


• Report on project status to client and management; generate weekly status, site, and enrollment reports


• Ensure timely updates to project tracker, including study enrollment


• Contact sites for query and data follow up


• Schedule project meetings, generate agendas and document meeting minutes


• 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)


• Clinical Research Coordinators (CRC) are ideal candidates 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 groups and individuals with little supervision


• Must have superior attention to detail and excellent oral and written communication skills and ability to excel in a team environment


• Must have the ability to work independently, multitask, and work to critical time-lines under pressure


• Must have strong time management and organizational skills


• Ability to prioritize workload to the changing needs of the day-to-day business


• Work precisely and in compliance with all procedures, rules, and regulations


• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.


• Self-motivated and able to grasp new concepts and learn quickly

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 REQUIREMENTS

Estimated 10-20% travel (domestic and international)