Clinical Study 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

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

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

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

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

generate weekly status,site, and enrollment reports

EDUCATION AND EXPERIENCE

CLINICAL PROJECT COORDINATOR II

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

Act as primary contact for clinical trial site activities

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

Provide study documents for audit to Study Compliance member as needed

Verify all processes and procedures to maintain compliant standards of the study

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

Train the new CPCs on the CPC tasks and mentor them as they are assigned to

various trials

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

generate weekly status,site, and enrollment reports

Perform other duties as assigned by supervisor

EDUCATION AND EXPERIENCE

SKILLS

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

we always do the right thing

we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives

we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday

we enjoy advancing clinical trials, helping patients, and celebrating success

we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else