Source Verification: Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records.
Communications: Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos and general correspondence. Escalates serious issues as per company’s escalation process when appropriate.
Training: Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitors and maintains site personnel list, qualification and training records.
Compliance: Ensures compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WIs, policies & procedures. Ensures any identified site non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support internal quality audits and regulatory inspections, as required.
Event Reporting: Ensures that all reportable events are identified, clearly documented and reported per protocol and per applicable requirements and regulations.
Collaboration: Participates in study-specific meetings, teleconferences and training. Collaborates with cross-functional team members and study sites throughout all study phases.
Documentation: Manages study request/collection of relevant (i.e. regulatory documents) investigator/site documentation.
Study maintenance: Updates and maintains study-specific monitoring milestones in Clinical Trial Management Systems.
Qualifications
Bachelor’s Degree, or an equivalent combination of experience and education.
Fluency in Italian and English (written and spoken); any additional European language (Spanish) is a nice-to-have.
Research Coordinator or Clinical Research Associate experience.
Experience in Clinical Field Monitoring.
Any experience working with CTMS (Clinical Trial Management Systems) or Electronic Data Capture systems is welcomed.
Good organizational skills.
Strong communication & presentation skills.
Comfortable interacting with clinical research site personnel.
Ability to work in team.
Ability to multitask: support several studies and/or personnel simultaneously.
Ability to work in a very fast-paced and dynamic environment.
Comfortable travelling up to 80% of time, mainly in Italy, but not excluding short travels abroad.
