Research Program Integrator

GE HealthCare•Waukesha, WI

3d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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, 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.
Negotiate budgets and contracts with external partners and process payments.
Complete IRB submissions such as new study submissions, Continuing Review, Amendments, Deviation reports, and Adverse Event reports.
Conduct training and provide guidance to study staff.
Facilitate regular monitoring visits and prepare for audits.
Serve as the main point of contact for research volunteers and study staff.
Implement process improvement activities as needed.
Implement electronic processes to enhance compliance and efficiency.