12 set - Roma
Tfs Healthscience
CLINICAL RESEARCH ASSOCIATE - BASED IN ROME - HYBRID (3 days working at the office)
About this role
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.
The Clinical Research Associate (CRA) is part of Clinical Development Services (CDS) or 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
- Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
- 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 with GCP and ICH guidelines and local regulatory requirements.
- Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
- Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
- Update CTMS and all other required by projects systems with accurate site level information
Qualifications:
- Bachelor’s Degree,
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