Clinical Research Coordinator

2 weeks ago


San Mateo, California, United States Axelon Full time
Job Overview

The Ultrasound segment, a fast-growing business in Client HealthCare, is the global leader in ultrasound medical devices and solutions. 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.

Caption Health, a part of Client Healthcare, focuses on developing clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans.

Essential Responsibilities
  • Oversee the smooth execution of internal research studies, including scheduling, recruitment, patient consent, and administering questionnaires.
  • Manage IRB submissions and study progress for internal and external research studies, ensuring documentation and requirements are up to date.
  • Appropriately maintain regulatory binders, subject binders, and CTMS for research studies.
  • Coordinate and organize clinical staff resources for internal research study execution.
  • Assist the field Clinical Development team with administrative tasks for all clinical trials, including tracking study status and enrollment, managing research budgets, and maintaining up-to-date regulatory documents as required.
  • Collect and export data obtained from research studies for analysis by the team.
  • Assist in coordinating labeling efforts and panel reads by external physicians and sonographers.
  • Ensure adherence to research regulatory, ethical, and safety standards.
  • Ensure necessary supplies and equipment for a study are in stock and in working order.
  • Occasional travel to clinical trial sites to provide assistance.
  • Perform other duties as assigned.
Basic Qualifications
  • Bachelor's degree in a science or health-related field or equivalent education and experience.
  • 3-5 years of experience in healthcare or clinical research is strongly desired.
  • Understanding of ICH-GCP guidelines.
  • CCRC certification is a plus.
  • Highly detail-oriented.
  • Exceptional interpersonal skills.
  • Proven communication skills, both written and verbal.
  • Excellent organizational skills.
  • Proficiency in Microsoft Office applications.
  • Must be willing to travel as required (up to 10%).
  • 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.
Eligibility Requirements
  • This position is based in the Client States only, in Houston or the Greater San Francisco Area. Legal authorization to work in the U.S. is required.
  • Must be willing to travel as required.
Desired Characteristics
  • Well-organized and structured, high attention to detail.
  • Ability to work independently and systematically.
  • Knowledge of Quality Management Systems (QMS).


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