Job Type: Full Time
Salary: 22,000 RON
We are currently recruiting for an experienced Clinical Study Administrator in Romania to work in a sponsor dedicated role for a global biopharmaceutical company.
In this role you will assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
What you will be doing:
- Assists in coordination and administration of clinical studies from the start-up to execution and closeout
- Collects, assists in preparation, reviews and tracks documents for the application process.
- Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents
Serves as local administrative main contact and works closely with the CRAs and/or the Study Managers for the duration of the study
- Set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
- Liaises with internal and external vendors
- Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
Your profile
- Bachelor’s degree in a scientific or healthcare-related field.
- Ability to work 3 days per week from the sponsor’s office
- Previous administrative experience in clinical research such as: eTMF/ISF/Veeva Vault documentation management, support with submissions documents preparation/collection, payments processing and calculation, etc
- Proven organizational and administrative skills.
- Computer proficiency
- Good knowledge of spoken and written English and Romanian.
- Ability to work collaboratively in a fast-paced environment with attention to detail.