GE HealthCare Clinical Research Project Manager RN PA 

United States, Wisconsin 

504372238

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

Roles and Responsibilities

Duties include (but are not limited to):

• Project Management:

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

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

• 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.

• 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.

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 from the National Commission on Certification of Physician Assistants (NCCPA)

Experience and Skills:

• 4+ years' experience of demonstrated and progressive responsibility in project management of clinical research and development studies in a clinical setting, industry, government agency,

• 4+ years' experience of demonstrated understanding and experience with Good Clinical Practices (GCP) and global and regional research or device regulations

Desired Characteristics:

• Professional certification in Project Management (PMP) or clinical research (CCRP, CCRA, or CCRN)