Clinical research associate

Main activities:
• Clinical study site management/monitoring activities in compliance with ICH-GCP, including Initiation, Ongoing and
Closeout visits;
• Ensure compliance with Sponsor SOPs, Local Laws & Regulations, Study Protocol, Site Monitoring Plan and associated
documents;
• Remote and on-site monitoring & oversight activities to ensure that data generated at site are complete, accurate and
unbiased and that subjects’ right, safety and well-being are protected;
• Support Essential Documents Management;
• Generate visit reports and prepare follow-up letters;
• Systems knowledge: CTMS Spectrum, eCRF Inform, IRT systems, CLMS, eTMF Veeva Vault;
• Support Quality activities: Audits and In-house Quality Control activities;
• Collaborate in various tasks requested by other sponsor roles.

Main activities:
• Pharmacovigilance activities - National and International Periodic Scientific Literature Search; Marketing Authorisations
- Type IA, IB and II variations, preparation and analysis of SmPC, PIL and labels;
• Support to daily regulatory activities;
• Regulatory support - artworks review; promotional and non-promotional material review (medicinal products, food
supplements and cosmetics);
• Medical Writing: Technical and Scientific translations.

Main activities:
• Analysis of clinical, financial and other information to determine the risk of the insurance process;
• Analysis of health questionnaires to determine the risk;
• Implementation and project management to improve the efficiency of the department;
• Development of training projects;
• Verification of daily production delivered to the department;
• Organization of documentation entry for distribution in the department;
• Verification of tele-underwriting, allocation and distribution of proposals;
• Conduction of meetings and minute elaboration.
• Reports;

Main activities:
• In vitro culture of various AML cell lines;
• Virus production;
• Transduction of AML cell lines to track single-cell lineages in each one;
• Flow cytometry;
• In vitro treatment of AML cell lines with chemotherapy (different combinations of cytarabine, doxorubicin and
decitabine);
• Study of treatment resistance and study of kinetics of cell growth and transduction.

Dissertation: “Disseção quantitativa da dinâmica subclonal subjacente à recidiva de Leucemia Mielóide Aguda”.

Publication: Caiado, F., Maia-Silva, D., Jardim, C., Schmolka, N., Carvalho, T., Reforço, C., Faria, R., Kolundzija, B.,
Simões, A., Baubec, T., Vakoc, C., Gomes da Silva, M., Manz, M., Schumacher, T., Norell, H. & Silva-Santos, B. Lineage
tracing of acute myeloid leukemia reveals the impact of hypomethylating agents on chemoresistance selection. Nat
Commun 10, 4986 (2019)

Main activities:
• Isolation of monocytes;
• Monocyte differentiation into dendritic cells;
• Flow cytometry;
• In vitro culture of various cell lines of lung and breast cancers and characterization of their HLA profiles.

Main activities:
• PCR to detect the HLA-B27 gene;
• Urine smears;
• Help in the preparation of clinical analysis.