The role of the Clinical Operations Assistant is to complete administrative tasks on behalf of assigned Project Clinical Team member which might include site management tasks during the different phases of a clinical trial as startup, maintenance and termination, contributing to the efficiency, accuracy, and quality of the trials.

Clinical Operations Assistants / Senior Clinical Operations Assistants are not sponsor facing but might be site facing, Senior Clinical Operations Assistant might be asked to assume a leadership position, guiding Clinical Operations Assistant team on large studies, participating in company initiatives and supporting the completion of additional tasks on behalf of Clinical Leadership Team.

Key Accountabilities:
Project Initiation & Planning
- Contribute to site activation by:
- Assisting/ with the site staff access to vendor systems
- Access reconciliation quarterly
- Following-up with sites to ensure staff training completion required by the study, including but not limited to vendor systems




- Coordinating the Investigator’s Site File printing and shipment to sites as per the instructions received from the project team
- Assisting with the material / equipment shipment to sites

Project maintenance
- Contribute to the project management by providing requested data to the clinical project leadership team (e.g. Principal investigator availability, etc )
- Contribute to site maintenance and guarantee inspection readiness by:
- Managing with quality the Trial Master File (TMF), which includes, but is not limited to: upload documents on time, assist with the update of the Expected Document List (EDL) on and ongoing basis and take the applicable actions to prevent and resolve Quality Issues (QIs).
- Follow up with site staff members and internal study team members regarding pending documents, needed information or pending actions (e.g. trainings to be completed, data to be added to the Electronic Data Capture (EDC), verification of safety info

📌 Clinical Operations Assistant (Mumbai)
🏢 Parexel
📍 Mumbai