As a Clinical Trial Coordinator, you will play a key role in advancing clinical research by supporting the planning, execution, and oversight of global trial operations. Your responsibilities will include coordinating trial-related tasks, maintaining accurate documentation, and ensuring adherence to regulatory standards and internal procedures.
Key Responsibilities
- Carry out assigned coordination duties for clinical trials, following defined task matrices and project requirements.
- Conduct file reviews at departmental, country, and investigator levels, recording outcomes in designated systems.
- Support the upkeep of study documentation, including training trackers, team rosters, access permissions, and activity plans.
- Maintain electronic Trial Master Files (eTMF) by following review schedules and logging findings appropriately.
- Provide system support for platforms such as GoBalto and eTMF, ensuring accurate data entry and accessibility.
- Assist with Risk-Based Monitoring (RBM) initiatives and contribute to data analysis and reporting.
- Process and transmit study documents to clients and central IRBs/IECs, ensuring timely delivery and compliance.
- Organize and schedule internal and client-facing meetings, preparing minutes and action items as needed.
- Track regulatory submissions and local requirements, supporting compliance across jurisdictions.
- Support the preparation and distribution of Investigator Site Files, pharmacy materials, and non-clinical supplies.
- Review and verify translated study materials when requested, ensuring accuracy and consistency.
- Attend kick-off meetings as needed, contributing through note-taking and follow-up support.
Qualifications
Successful candidates will hold a secondary school diploma or equivalent, along with formal training or experience that demonstrates the ability to perform the duties of the role—typically gained through at least four years of relevant work. A bachelor’s degree is preferred but not required.
Essential skills include strong organizational abilities, meticulous attention to detail, and the capacity to manage multiple priorities efficiently. You must be comfortable working both independently and within team environments, adapting quickly to shifting project demands.
You should have solid proficiency in MS Office applications (Word, Excel, PowerPoint) and the ability to learn clinical trial management systems. Familiarity with GoBalto and eTMF is an asset. Strong written and verbal English skills are required, along with a solid understanding of ICH GCP guidelines, applicable country regulations, and standard operating procedures.
This position supports ongoing training and development, emphasizing continuous improvement, global collaboration, and cross-functional coordination throughout the lifecycle of clinical projects.
