CRA / SENIOR CRA - Homebased (Italy)
Temporary (1 year with possibility to be extended)
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Clinical Research Associate home-based in Italy
About This Role
The Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions (SRS) within TFS Health Science and will function operationally as a member of a Project Team and is responsible for the initiation, on–site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements.
Key Responsibilities
- Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.

- Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
- Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
- Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
- Verify proper management and accountability of Investigational Product.
- Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escape observed deficiencies and issues as appropriate.
- Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
- Timely delivering site documents to eTMF or paper TMF; verify that the Investigator'

(Senior) Clinical Research Associate

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