Clinical Trial Coordinator Jobs

Clinical Trial Coordinator day-to-day activities:

•Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable

•Sets-up systems

•Supports vendor selection, TPRM process, SIM entries

•IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking

•Supports Vendor set-up as applicable

•Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)

•Supports preparation and translation of ICF into local languages (including vendor management if necessary)

•Supports preparation of patient facing material

•Responsible for completeness of uploaded trial related documents into CREDI/SUBWAY, including archiving of paper TMFs

•Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments

•Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

•Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial

•Implements innovative and efficient processes which are in line with Client strategy

Education:

• Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations

Languages: Fluent in both written and spoken English, local language as needed

Experience/Professional requirement:

• Ideally several years of working experience with 1+ years´ of experience in clinical operations
• Understanding of clinical drug development with particular emphasis on trial setup, and contracting