Description
We are looking for Experienced Clinical Research Associates to join our team and support the successful execution of clinical trials by performing high-quality monitoring and site management activities.
In this role, you will ensure that study sites operate in compliance with protocols, GCP/ICH guidelines, regulatory requirements, and sponsor expectations while maintaining strong communication and collaboration with site staff and internal teams.
Responsibilities
- Conduct selection, initiation, monitoring, and close-out visits according to GCP, ICH guidelines, and the contracted scope of work.
- Work with sites to develop and track subject recruitment plans aligned with project timelines.
- Provide protocol and study-specific training to site personnel; maintain regular communication to support expectations and resolve issues.
- Assess site performance and ensure adherence to protocol, study procedures, and regulatory compliance; escalate quality issues when appropriate.
- Track study progress (regulatory submissions, approvals, enrollment, CRF completion, and data queries) and support start-up activities when needed.
- Ensure essential documents are properly maintained in the TMF and verify ISF compliance with GCP and local regulatory standards.
- Document site management activities through timely monitoring visit reports, follow-up letters, and required study documentation.
- Collaborate with cross-functional study team members to support operational excellence.
- When applicable, support site-level recruitment planning and site financial management.
Qualifications
- Bachelor’s degree in a scientific or healthcare discipline, or equivalent experience.
- Minimum of 1 year of on-site monitoring experience.
- Good knowledge of GCP, ICH guidelines, and clinical research processes.
- Proficiency in Microsoft Word, Excel, PowerPoint, and digital tools.
- Strong written and verbal communication skills in English.
- Excellent organizational, time-management, and problem-solving abilities.
- Ability to build strong working relationships with sites, colleagues, and sponsors.