Job Description Summary

The Clinical Research Project Manager (Research Program Integrator - RPI) is responsible for managing research activities within the Ultrasound businesses at GE Healthcare. This role involves leading cross-functional planning, tracking, status communication, and execution of research projects. The RPI oversees the entire lifecycle of research projects, from strategic planning through development, active management, and closure, ensuring all quality, content, schedule, and budget targets are met. A key part of the role will involve serving as clinical research coordinator for a large clinical trial.

Job Description

**not open to Sponsorship or OPT for this role**

Roles and Responsibilities 

Duties include (but are not limited to): 

• Project Management: Oversee defined research activities to meet strategic research needs. Coordinate regularly among external collaborators and internal stakeholders. 

• Compliance: Ensure research activities comply with study protocols, external standards (IRB policy, GCP, regional regulatory requirements, and internal GEHC requirements (Phased Review Discipline, QMS, SOPs),. 

• Team Leadership: Lead cross-functional research teams to conduct internal and external research activities, delivering required outcomes per business needs and study plans. 

• Documentation: Develop necessary research documents, including protocols, plans, informed consent forms, source documents. Maintain investigator site file documentation, including regulatory binders, source documentation, and trackers. Maintain study records in systems like Clinical Trials Management System, MyWorkshop, and regional regulatory records. 

• Budget and Contracts: Negotiate budgets and contracts with external partners and process payments. 

• Participant Management: Recruit, screen, enroll, and obtain informed consent from study participants. 

• Session Coordination: Oversee research sessions, including scheduling, reserving space, ensuring staff training, and managing documentation. 

• IRB Submissions: Complete IRB submissions such as new study submissions, Continuing Review, Amendments, Deviation reports, and Adverse Event reports. 

• Staff Training: Conduct training and provide guidance to study staff. 

• Monitoring Visits: Facilitate regular monitoring visits and prepare for audits. 

• Communication: Serve as the main point of contact for research volunteers and study staff. 

• Facility Maintenance: Maintain facilities, order supplies, and track spending. 

• Process Improvement: Implement process improvement activities as needed. 

• Electronic Processes: Implement electronic processes to enhance compliance and efficiency. 

Location Requirement: This role requires physical presence at the GEHC Research Park facility in Wauwatosa, WI, or the GE HealthCare Institute in Pewaukee, WI, during ultrasound scanning sessions.  Will require travel to study sites during trial execution.   

Required Qualifications 

Either a RN or PA 

For Registered Nurse (RN): 

• Bachelor's degree in Nursing (BSN) 

• Current state RN license 

For Physician Assistant (PA): 

• Master's degree from an accredited PA program 

• Certification