Job Title
Clinical Research Coordinator
Report Line
Director Clinical Development
Location
Australia - Clinical Development Department
Purpose of Job
This role provides administrative support to clinical trials in compliance with Standard Operating Procedures (SOPs), ICH-GCP and local regulations.
Key Responsibilities
* Support the full spectrum of research activities, including study start up, site management and site closure.
* Prepare documents for clinical trial applications for submission and approval from the competent authority and ethical committees.
* Maintain accurate filing and archiving of clinical trial documents and study files.
* Coordinate meeting activities, such as planning and organizing investigator-, project-, team- meetings and providing meeting minutes.
* Implement new CTMS system, project tracking and maintenance of eTMF.
* Liaise with cross-functional project teams to support the management of clinical projects, communicating with Science, Medical, Data Management, IP teams within the organization.
* Maintain communication with vendors as needed (e.g. central lab, IP distributor, CRO).
* Interact with sites and co-monitor as needed.