Research Program Integrator

HC1316 GE Precision Healthcare LLC; Waukesha (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

GE HealthCare in the United States seeks a Research Program Integrator to manage research activities for OB AI products and obtain FDA clearance. You will lead cross-functional planning, track progress, communicate status, and drive execution across the full lifecycle from strategy to closure, ensuring quality, schedule and budget targets are met.

Responsibilities include overseeing research activities, coordinating with external partners, ensuring IRB and GCP compliance, developing protocols

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.
• Experience managing research projects in a medical device or pharmaceutical company.
• Patient-facing experience and experience with sponsored studies.
• Strong understanding of Good Clinical Practices (GCP) and global/regional regulations.

Responsibilities

• Oversee defined research activities to meet strategic research needs.
• Coordinate regularly among external collaborators and internal stakeholders.
• Ensure research activities comply with study protocols, IRB policy, GCP and regulatory requirements.
• Lead cross-functional research teams to conduct internal and external activities.
• Develop necessary research documents, including protocols, plans, consent forms and source documents.
• Maintain investigator site file documentation and regulatory binders.
• Negotiate budgets and contracts with external partners and process payments.
• Complete IRB submissions such as new study submissions and continuing reviews.
• Train study staff and prepare for audits.
• Maintain study records in CTMS, MyWorkshop, and regional regulatory records.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge (GCP/IRB)

Documentation & records management

Budget & contracts negotiation

Education

Bachelor’s degree in life sciences, engineering, clinical field, or equivalent

Tools

Clinical Trials Management System

MyWorkshop

Job 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.

Roles and Responsibilities

• 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).

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

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).

Relocation Assistance

No

At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.