Key Roles & Responsibilities

1. Provide Support in clinical trial/research projects:

• Provides support to project team on study design and development of study protocols and study-related documents (e.g., ICF, IAF, DCs…), standard operating and GXP procedures in the provision of technical guidance
• Accompany CRO on-site visits for assigned studies
• Coordinates internal and external clinical operations activities of assigned study team
• Proactively identifies project risks and resolves with project team and Head of Clinical Operations and Trial Management
• Oversee the monitoring CRO in collaborates with Clinical site coordinator to ensure clinical sites and investigators are conducting studies in compliance with local requirements, ICH-GCP guidelines, and the study protocol
• Conducts/oversee the Clinical Operations activities i.e. develops study related document, prepares regulatory documents submission, and monitors submission of project-related institutional review board (IRB)-documents performed by the monitoring CRO
• Prepares, coordinates, and monitors Clinical trial supplies and shipments with the CRO as applicable
• Communicates with the Manufacturer to ensure the quality of IP and IP handling including arrangement of IP shipment, monitoring its delivery under the required condition, and overseeing the IP handling procedures as per agreement
• Maintains/oversee the essential documents for the sponsor i.e. Trial Master File and periodically QC
• Oversees the clinical sites’ adherence to the regulatory and approved protocols through review of monitoring and audit reports, communicates with investigators, study site personnel, CRAs and other CRO/designee personnel
• Oversees the CRO’s activities to support the IVI project or study team

2. General Duties and Functions

• Contributes to the development of MOP and SOPs with the Head of Clinical Operations and Trial Management and Project Lead, as required.
• Proactively lead the discussion and coordinate the subject related to clinical operation with the Project Team and all stakeholders in the regular team meetings, and conference calls, and take minutes of meetings including follow-up of action items for clinical operation-related subjects.
• Proactively coordinate the CAPA responses in a timely manner, as needed
• Provides support in coaching, and training new members
• Develops monitoring tools and department initiatives, as needed
• Other assignments, as required

* Fluency in both French and English is required.