06 ott - Roma
Tfs Healthscience
SENIOR CRA - HOMEBASED ITALY
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 Senior 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; escalate 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's Site File
(ISF) is maintained in accordance w
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