Job Summary
The Senior Clinical Research Associate (CRA) for Medical Devices plays a pivotal role in the oversight and implementation of clinical trials, ensuring compliance with regulatory standards and fostering successful research outcomes. This position involves providing practical guidance, maintaining study timelines, and ensuring the quality of clinical data.
Responsibilities
- Manage and supervise clinical trial activities from initiation through completion.
- Conduct site visits to monitor study progress and compliance with protocols.
- Collaborate with various teams to facilitate trial execution.
- Review and approve study documents such as protocols and consent forms.
- Train site personnel and ensure adherence to Good Clinical Practice (GCP) guidelines.
- Identify and resolve issues that may arise during the study.
- Prepare reports and documentation related to trial progress and outcomes.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- Minimum of 5 years of clinical research experience, with a focus on medical devices preferred.
- Thorough understanding of clinical trial methodology and regulatory requirements.
- Strong communication and interpersonal skills.
- Ability to work independently and lead project teams effectively.
- Knowledge of data management and monitoring tools.
