Maria Fausta Pontrandolfi

Lead CRA on 3 international clinical trials, coordinating country CRAs team and acting as Local Trial Manager:

• Responsible for Country CRAs team on relevant tasks such as patients’ recruitment, interim analysis, DB lock and data cleaning.
• Responsible for Country strategies being the first point of contact for regional Clinical Lead.
• Manage project team collaboration, communication planning and reporting within the CRAs team and local key cross-functional stakeholders such as Clinical Trial Assistant (CTA) and Clinical Specialist Activation (CSA) teams.
• Build site and Country patient enrollment strategies to get the recruitment target.
• Interface with Sponsors’ Local Affiliate as Sponsor Point of Contact.
• Responsible for periodic presentation to the local Management and Country Head on the status of the recruitment and project enrollment strategies planning.
• Buddy CRA: support to junior CRAs on technical competencies to consolidate skills.
• Responsible for Accompany Site Monitoring Visits to junior CRAs (on behalf of Line Manager).
• Subject Matter Expert in Site Initiation Visit workshops included in IQVIA Career Camp (Clinical Operations Internship School)
• Subject Matter Expert: speaker at the University of Pavia (Italy) at Master Discipline Regolatorie "G.Benzi" about the pharmaceutical industry, job market, CRO and main professional roles

Developed skills: excellent communication, leadership, ownership, critical thinking, coordinating, team player.

• Performing site initiation, monitoring and close-out visits (remote and onsite), conduct monitoring in RBM Clinical Trials.
• Provide a subject recruitment planning to discuss about with the sites.
• Managing Interim Analysis and DBLs ensuring projects aiming within project timelines. Developed skills: negotiation, analytical thinking, innovation, adaptability.

• Performing monitoring visits (remote and onsite) in accordance with ICH-GCP and SOPs.
• Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Contribute to ensure site’s documentation is complete, current, stored appropriately and sites’ audit-readiness.
• Managing preparation for two audit in different sites, which includes bi-weekly calls with country Quality Specialist to review the status of the site to prevent findings and CAPA resolution timelines.
• Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.
• Manage the case report form (CRF) completion and submission, and data query generation and resolution. Developed skills: detailed oriented, accurate, problem-solving, time-management, self-reliant.

• Supporting the Clinical Project Leader in the management of clinical trials on national and international territory for which Aboca S.p.A Agricultural Companyis the Sponsor.
• Planning and time line for the start-up, conduct and data management of activities related to sponsored and / or spontaneous randomized clinical trials
• Participation in project team meetings with Aboca personnel and meetings with management
• Collaboration with the CRO for all the activities of conducting a clinical study
• Drafting of company SOPs to implement the Quality System for the management of clinicaltrials