Inês Tavares Cabrita

Multisponsor

• Managing 6 protocols across 15 sites in oncology, haematology, and respiratory:
  - Head & Neck Squamous Cell Carcinoma (Phase II/III)
  - Chronic Lymphocytic Leukemia & Richter’s Syndrome (Phase Ib/II)
  - Gastric/Gastroesophageal Junction Cancer (Phase III)
  - Extensive-Stage Small Cell Lung Cancer (Phase III)
  - Pulmonary Emphysema due to Alpha-1 Antitrypsin Deficiency (Phase III)
• Conduct SIVs, IMVs, and COVs; act as main contact for site staff, ensuring GCP and protocol adherence.
• Supported sponsor audits at sites in 2025 — preparation, document reconciliation, and corrective action follow-up.
• Responsible for site training on protocol amendments, safety reporting, and system use.

Sponsor dedicated to MSD

• In addition to the general CRA activities and responsibilities, worked on phase II and III lung cancer studies (fully dedicated to Oncology), ensuring compliance with Good Clinical Practice (GCP), protocol, and regulatory requirements.
• Conducted key site management activities including Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) for a portfolio of investigative sites.
• Collaborated closely with cross-functional teams, including clinical operations and medical teams, to support trial execution and ensure data quality.
• Provided continuous support to sites, including training, issue resolution, and regular communication, contributing to high site engagement and performance.

Sponsor dedicated to Sanofi

• In addition to the general CRA activities and responsabilities, managed and monitored 6 phase II & III clinical trials across Haematology (Immune-mediated Thrombotic Thrombocytopenic Purpura), Nervous System (Multiple Sclerosis), and Oncology (Small Cell Lung Cancer), ensuring compliance with GCP, study protocols, and regulatory standards.
• Supported the execution of double-blind, open-label, randomised, multicentre trials in adult subjects across multiple therapeutic areas, contributing to trial success and high-quality data collection.

Multisponsor

• In addition to the general CRA activities and responsibilities, worked as Multisponsor on 7 phase Ib/IIa, II, III, and III/IV double-blind, open-label, randomised, multicentre, single-centre, and non-interventional clinical trials in the following therapeutic areas: Allergy (Allergic Rhinitis, Peanut Allergy – Paediatric), Digestive System (Primary Biliary Cholangitis), Nervous System (Multiple Sclerosis), Rare/Genetic Diseases/Disorders (Huntington’s Disease – Phase Ib/IIa), and Vaccines (COVID-19). Involved adult, paediatric, and adolescent subjects.
• As an unblinded CRA, conducted unblinded Interim Monitoring Visits with responsibilities including the review of Pharmacy Binders, IP allocation and accountability, stock reconciliation, and monitoring of storage conditions.
• Acted as the Lead CRA on two studies, and performed Annual Site Operations Assessments (SOA).

• Performed administrative tasks, including the timely processing of documents to PPD/Sponsor eTMF, and preparing Investigator Site Files (ISF) for study site activation.
• Regularly reviewed eTMF documents and CTMS data to maintain good metrics.
• Reviewed and tracked regulatory documents.
• Effectively communicated with study sites and the project team to resolve pending invoices, and reconcile eTMF findings.
• Volunteered to participate in the important PPD eTMF initiative by recording training videos for Veeva Vault eTMF.
• Acted as a Remote Site Monitor (RSM) on a phase II multicentre, open-label clinical trial in Rare/Genetic Diseases/Disorders (Systemic Sclerosis), involving adult subjects.
• Performed Site Management Calls (SMCs) and managed all site management activities that could be performed remotely as the Primary Site Contact, supporting interim analysis, database locks, site payments, findings, missing documentation, eCRF queries, etc.
• Assisted the Data Excellence Team UK & Ireland by following up on outstanding site payments that were overdue by 120+ days across approximately 50 projects, where action was pending from the site/Clinical Team.