Clinical Research Associate
- Italia
- Tempo indeterminato
- Full time
- Identify investigator sites and participate in the feasibility process for new studies
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
- Perform visits remotely according to foreseen applicable procedures and timeframes
- Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission
- Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets
- Check the correct submission and completion of informed consent forms
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
- Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures
- Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Enthusiastic, knowledgeable and proactive
- University degree in a scientific/life science field
- At least 2 years of experience in managing and conducting clinical trials
- In depth knowledge of ICH GCP principles
- Able to carry out independently all the activities related to the monitoring of clinical trials
- Good knowledge of Office Suite (Word, Excel, PowerPoint)
- Organizational and problem-solving skills
- Excellent written and verbal communication skills including good command of English language