03 ott
|
Tfs Healthscience
|
Lazio
03 ott
Tfs Healthscience
Lazio
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; 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'
📌 (Senior) Clinical Research Associate (Lazio)
🏢 Tfs Healthscience
📍 Lazio