Job In Pharma
Job In Pharma
We are looking for a CRA FREELANCE ideally based in Rome, with responsibility for Lazio, Umbria, Abruzzo e Sicilia.
This role will manage and perform activities at a site level associated with study start-up and study management.
Opportunities of growth (as CRAII or even Senior CRA) will be offered to talented candidates.
- Regulatory document collection
- Preparation of ethics submission documents
- Preparation and negotiation of Investigator Site Contract/budget negotiations for assigned studies
- Monitor the progress of the Clinical Study at Investigator Sites and ensure that clinical trials are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements
- Participation to Study Team meetings, Investigator’s meetings and Departmental Meeting
- Case Report Forms (CRF) review
- Update study-tracking tools and databases with site status
- Document all budget & contract activities in tracking database
- Liaise with the internal team to resolve any site queries regarding the contract
- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
– Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
– Excellent understanding of Serious Adverse Event (SAE) reporting
– Ability to resolve project-related problems and prioritize workload for self and team
– You must have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
- International degree or its international equivalent in clinical science or health related field from an accredited institution;
- 2-5 years clinical monitoring experience
- Experience with investigative site start-up documents
- Good understanding of clinical trial execution
- Fluency in English
- Based in Rome but available to travel