Description
As a Clinical Research Associate at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will monitor the progress of clinical studies at the site level 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.
Key responsibilities include:
- Conducting thorough reviews of subject source documents to ensure protocol requirements are met
- Verifying data recorded on Case Report Forms against source documents
- Ensuring clear written communication to clinical sites and project team members
- Training site personnel and maintaining their qualification and training records
- Identifying and addressing non-compliance issues
- Supporting regulatory inspection activities
- Participating in study-specific meetings and collaborating with cross-functional team members
Requirements:
- Minimum of 1 year of medical device experience
- Minimum of 2 years of site monitoring experience
- Bachelor's degree or Registered Nurse (RN) qualification
- Ability to travel up to 60%
- Therapeutic experience aligned with at least one Boston Scientific division
- Proficient with MS Office skills (Word, Excel, PowerPoint, Teams)
- Prior experience with Medidata RAVE and VEEVA Vault preferred
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.