Libera Basile
Milan
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers new professional challenges in an international environment.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
OPIS
01.2023 - Current
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Submitted routine reports and follow-up letters to facilitate internal and external communication.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Regulatory Affairs Intern
Sandoz Pharma
07.2023 - 12.2023
- Assisted in the preparation of regulatory submissions for timely approvals.
- Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Implemented regulatory guidance procedures to mitigate the risk of nitrosamine impurities in human medicines across company portfolio.
- Supported the development of regulatory strategies for new products, ensuring timely market entry.
- Evaluated promotional materials for adherence to regulations, minimizing potential risks associated with off-label promotion or false claims.
- Collaborated with quality assurance department to guarantee that products met regulatory standards while in production, reducing the likelihood of product recalls or enforcement actions.
- Prepared and submitted regulatory file applications and supporting documentation.
- Received, researched and resolved consumer inquiries.
Hospital Pharmacist
Azienda Unita' Sanitaria Di Ferrara
02.2022 - 05.2023
- Improved medication safety by conducting thorough reviews of patient profiles and making appropriate recommendations.
- Worked as preceptor to provide practice-based instruction to students at pharmacy practice sites.
- Optimized drug therapy outcomes for patients by providing comprehensive medication management services.
- Streamlined pharmacy operations by implementing efficient workflow strategies and inventory control measures.
- Performed critical medication reconciliations upon patient admission and discharge to minimize adverse drug events associated with transitions of care.
- Responded to queries regarding dosages, indications and drug availability.
- Handled stock and order supplies of medicines and drugs.
- Verified safety and accuracy of physician orders.
- Reviewed and monitored patient past and present medication records, checking for errors, incompatibilities and adverse reactions to avoid future complications.
- Maintained patient and medication records in compliance with government regulations and department policies and procedures.
- Managed drug and supply inventories.
- Counseled patients regarding proper intake of medications.
Education
Post Graduate Master's Degree - Drug Development And Clinical Application
Università Cattolica Del Sacro Cuore
Rome, Italy11.2022
Master's Degree - Pharmacy
Universita' Di Bologna
Bologna 03.2021
Skills
- Team working
- Detailed Documentation
- Clinical Study Report Writing
- Project Management
- Action Planning
- Team Training
Websites
Certification
- Certified Clinical research Associate, OPIS
Languages
Italian
Bilingual or Proficient (C2)
English
Intermediate (B1)
Timeline
Regulatory Affairs Intern
Sandoz Pharma
07.2023 - 12.2023
Clinical Research Associate
OPIS
01.2023 - Current
Hospital Pharmacist
Azienda Unita' Sanitaria Di Ferrara
02.2022 - 05.2023
Post Graduate Master's Degree - Drug Development And Clinical Application
Università Cattolica Del Sacro Cuore
Master's Degree - Pharmacy
Universita' Di Bologna
- Certified Clinical research Associate, OPIS
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