Job Summary

The GHEC Ultrasound segment, a fast-growing business in GE HealthCare, is the global leader in ultrasound medical devices and solutions. The portfolio spans the continuum of care to enable customers with ultrasound screening, diagnosis, treatment and monitoring of diseases. Our customers are seeking to improve efficiency in radiology and beyond and increase user confidence to provide better clinical outcomes continues to grow. Consequently, the need for AI, digital solutions, and automation, connecting devices and software in one seamless ecosystem continues to proliferate.

The Caption Health business unit focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans.

The Clinical Research Associate (CRA) is responsible for supporting Caption Health sponsored medical device clinical trials (software as a medical device) and research through site monitoring activities to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP, and other applicable regulatory requirements. The CRA also provides support in start-up, enrollment, follow up, and closure of clinical trial activities, while partnering with Clinical Operations teams (Data Managers, Statisticians, System Admin) and Clinical Project Managers to ensure strategic planning, resourcing, execution, and oversight of monitoring deliverables.

Job Description

** No Sponsorship for this role **

Essential Responsibilities:

In this role you will:

• Serves as the primary point of contact between the research site and GE HealthCare for all monitoring activities for multiple clinical trials across a range of medical devices and program teams, ensuring compliance with Good Clinical Practices, ISO 14155, and other applicable regulations.
• Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records
• Provides clear written communication to clinical sites and project team members through monitoring reports, follow up letters, study memos, and general correspondence. Thorough documentation and proper escalation of issues is essential in all visit reports.
• Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification, and training records.
• Ensures any identified protocol deviations are addressed, clearly communicated, documented, and escalated as requires through monitoring visits, analyzing study metrics, and general study data overview.
• Ensures that all reportable events are identified, clearly documented, and reported per protocol and applicable requirements/regulations.
• Attends internal and external meetings as necessary to facilitate discussion and decisions for monitoring strategy pertaining to study, regulatory, or GCP specific requirements.
• Responsible for developing Study Monitoring Plans, Monitoring Visit Reports (SQV, SIV, IMV, COV), follow-up letters, and Study/Monitoring Risk Assessments.
• Participates in team review and maintenance of QMS work instructions governing Study Monitoring, always striving to identify and implement opportunities for improvement.

Basic Qualifications:

• Bachelor's degree or equivalent
• 5-8 years' experience as a CRA, preferably with Medical Device experience
• Researcher with experience from site qualification to site wrap-up.
• Proven communication skills, both written and verbal
• Must be willing to travel as required (up to 60%).
• Working knowledge of clinical research operations and documentation
• Proven ability to drive multiple projects and initiatives in a cross functional environment while leveraging key stakeholders and engaging end users.

Desired Characteristics:

• Well organized and structured, high attention to detail.
• Ability to work independently and systematically.
• Knowledge of Quality Management Systems (QMS) including experience with GDP and CAPA.

For U.S. based positions only, the pay range for this position is $112,640.00-$168,960.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.