09 ott - Lazio
Trial Form Support
Overview
Senior Clinical Research Associate (home-based in Italy) joins Strategic Resourcing Solutions within TFS Health Science to monitor clinical trials and ensure GCP/ICH compliance.
You will work on-site and remotely as part of a project team, focusing on data integrity, participant safety, and regulatory adherence.
This role offers impact across study sites and an opportunity to contribute to a global CRO known for collaboration and patient-centric solutions.
You will shape monitoring strategies in oncology and other therapeutic areas with a supportive, cross-functional team.
Retribuzione / Benefits
Permanent contract
Salary gross/year (Level III)
Lunch vouchers
Health insurance
Pension
Car allowance where applicable
Responsabilità
Monitor on-site and remote clinical trials per SOPs, GCP and ICH guidelines; ensure subject safety and data quality
Verify informed consent and protocol compliance; protect participant rights
Review CRFs and source data for accuracy and validity
Verify Investigational Product accountability and handling
Timely reporting of monitoring findings and CAPAs; update tracking systems and escalate issues
Provide sites with issue lists and action items for timely resolution
Ensure timely delivery of site documents to eTMF/paper TMF; maintain ISF per regulatory requirements
Participate in audit/inspection preparation and follow-up
Order, ship and reconcile clinical supplies for sites, if applicable
Update CTMS and other project systems with accurate site-level information
Requisiti fondamentali
Bachelor's degree in life sciences or nursing, or equivalent
At least 5 years of clinical trial monitoring experience
3 years of oncology experience, preferably in early-phase trials
Strong knowledge of GCP/ICH guidelines and regulatory requirements
Fluent in English; strong written and verbal communication
Ability to work independently and in a matrix team; fast-paced environment
Good medical terminology and science understanding related to assigned drugs and therapeutic areas
Willingness to travel *****%, including overnight and abroad
Self-awareness
flexibility
proactivity
GCP/ICH regulatory knowledge
CTMS
eTMF
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