- Location
- Waukesha, United States of America
- Type
- Full-time
- Department
- Education
- Experience
- 5+ years
- Visa
- Not sponsored
- Source
- Workday
Description
Job Description Summary
The Research Program Integrator is responsible for managing research activities to develop Caption Health’s OB AI products and obtain clearance by the FDA. 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.Job Description
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.
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.
Process Improvement: Implement process improvement activities as needed.
Electronic Processes: Implement electronic processes to enhance compliance and efficiency.
Required Qualifications
- Bachelor’s degree in life sciences, engineering, clinical field, or equivalent.
- 5+ years of experience in clinical or technical research programs in a clinical setting, industry, government agency, or a similar role in a medical device or pharmaceutical company.
- The experience being in managing research projects or medical device research.
- Patient facing experience and experience working in/with sponsored studies
- Strong understanding of Good Clinical Practices (GCP) and global/regional research or device regulations.
- Proven ability to build and sustain cross-functional relationships.
Desired:
Professional certification in Project Management (PMP) or clinical research (CCRP, CCRA, or CCRN)
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No