About the position
The Site Monitor, also known as a Clinical Research Associate (CRA), plays a crucial role in ensuring the integrity and quality of clinical trial data while adhering to regulatory standards. This position is vital for maintaining compliance with ICH GCP (International Council for Harmonisation Good Clinical Practice) and local regulations at the site level. The Site Monitor will primarily conduct monitoring activities virtually, which will supplement on-site visits as necessary. This hybrid approach allows for flexibility while ensuring that all monitoring tasks are completed effectively and efficiently. In collaboration with the Site Manager, the Site Monitor will ensure that the clinical trial site is compliant with the study protocol and is always inspection-ready. This involves regular communication and coordination with site staff to address any issues that may arise during the trial. The Site Monitor will be responsible for reviewing data submissions, ensuring that all documentation is accurate and complete, and that any discrepancies are resolved promptly. The role requires a proactive approach to problem-solving and a commitment to maintaining high standards of data quality and integrity. The Site Monitor will also be expected to engage with various stakeholders, including site personnel and internal teams, to foster strong relationships and facilitate effective communication throughout the study. This position is essential for the successful execution of clinical trials and ultimately contributes to the development of therapies that improve patient health.
Responsibilities
- Ensure data integrity and quality at the clinical trial site.
- Monitor compliance with ICH GCP and local regulatory requirements.
- Conduct monitoring activities primarily in a virtual format, supplementing with on-site visits as needed.
- Collaborate with the Site Manager to maintain protocol compliance and inspection readiness.
- Review data submissions and resolve discrepancies in documentation.
- Communicate effectively with internal and external stakeholders to address issues and facilitate smooth operations.
Requirements
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- A minimum of 12 months experience as a clinical monitor with demonstrated experience in monitoring (virtual or onsite).
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Proficiency in local language preferred; English is required.
- Strong computer skills and ability to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Demonstrated networking and relationship-building skills.
- Ability to adapt to changing technologies and processes.
