Aline Nicoletti Email & Phone Number

Valinhos, São Paulo, Brasil

• Coordeno os estudos clínicos do Instituto Butantan, da Vera Therapeutics e da AstraZeneca;
• Realizo a gestão de atividades de 4 estudos clínicos e de equipe de 3 assistentes de pesquisa clínica;
• Registro dados dos participantes no documento fonte e no formulário de relato de caso eletrônico (eCRF/ATCGen/iMedidata), e resolvo queries (pendências abertas no eCRF), realizando a monitoria interna destes;
• Elaboro fichas clínicas, fluxogramas e check-list dos estudos sob minha… Show more
• Elaboro fichas clínicas, fluxogramas e check-list dos estudos sob minha coordenação;
• Controlo e arquivo documentos (submissões/aprovações do CEP, protocolo inicial e emendas do estudo, cartas de monitoria, currículos e certificados da equipe do centro, certificados de calibração de equipamentos, entre.

Campinas, São Paulo, Brazil

• Coordinate the “Gavotte” clinical trial, whose objective is to evaluate the efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab compared to the approved dose of the same in patients with primary.
• Process, sending biological samples (blood and urine) and monitoring the results of laboratory tests with the central laboratory (Labcorp);
• Record patient data in the physical medical record and in the electronic case report form… Show more
• Record patient data in the physical medical record and in the electronic case report form (eCRF/Medidata Classic Rave), and resolve queries (pending issues opened in the eCRF);
• Record data on the ERT portal and transfer MRI images to NeuroRX (Research Representative Organization responsible for analyzing study images);
• Receive, dispense and account for study medication (PI) in Almac/IXRS;

Campinas, São Paulo, Brazil

• Designed and planned a research project aimed at evaluating possible changes in the expression of plasma microRNAs in response to COVID-19;
• Submitted project and addendum to the institution's LEC;
• I wrote the Informed Consent Form (ISF), SOPs and technical-scientific reports for funding agencies such as CAPES and FAPESP;
• Processed blood samples (plasma separation), extracted RNA, synthesized complementary DNA, performed RT-PCR analysis;
• Implemented an extra rack agitation… Show more
• Implemented an extra rack agitation step in the RNA (microRNA) extraction, which resulted in 100% extraction efficiency;

Jundiaí, São Paulo, Brazil

• Taught theoretical classes in the various disciplines within the field of pharmacy;
• Developed individual and group exercises to fix the content learned in the classroom;
• Taught practical pharmacotechnical classes (preparation of syrup, preparation of saline solution, preparation of herbal extracts and preparation of homeopathic medicines);
• Taught practical classes on the application of injectables;
• Taught practical classes on first aid and vital signs measurement;
• … Show more

Campinas, São Paulo, Brazil

• Designed and planned a research project aimed at the pharmacological evaluation of guanosine in the corpus cavernosum (CC) isolated from mice, which opened the possibility of investigating the role of guanosine in an.
• Submitted projects to the institution's Animal Use Ethics Committee;
• Conducted in vitro experiments (concentration-response curves in isolated organs bath and ELISA test)… Show more
• Conducted in vitro experiments (concentration-response curves in isolated organs bath and ELISA test) and in vivo (measurement of intracavernous pressure in mice and rats);
• Analyzed quantitative data using Graph Pad Prisma statistics software;
• Prepared abstracts and posters for scientific congresses;

Jundiaí, São Paulo, Brazil

• Elaborated, implemented and revised the Good Practices Manual for Storage of Pharmaceutical Products and the company's Standard Operating Protocols;
• Controlled and renewed documents such as the Company Operating Permit (AFE), the Sanitary License (LS), the Technical Regularity Certificate (CRT), the Pest Control Certificate and the Water Quality Certificate;
• Participated in the elaboration of the Technical Evaluation Report (LTA) together with the health surveillance of Jundiaí and… Show more
• Participated in the elaboration of the Technical Evaluation Report (LTA) together with the health surveillance of Jundiaí and the contracted engineering team;
• Controlled temperature, pests (rodents and insects) and company water;
• Accompanied inspection visits (VISA and CRF);

Jundiaí, São Paulo, Brazil

• Performed application of injectable drugs intramuscularly and subcutaneously;
• Controlled psychotropic and antimicrobial drugs according to Portaria 344/98 and RDC 20/2011, respectively;
• Wrote the controlled prescriptions in the SNGPC (National Controlled Products Management System);
• Trained a team of pharmacy assistants and attendants, comprising approximately 10 employees;
• Attended customers and resolved doubts related to the rational use of medicines.

Valinhos, São Paulo, Brazil

• Microbiological analysis
• Performed the preparation of culture media and microbial counting;
• Performed microbiological monitoring of production areas and microbiological process validations;
• Analyzed injectable products (LAL test and sterility test);
• Performed sterilization of materials and culture media;
• Elaborated and revised SOPs and methodologies.Chemical physical analysis

Phd In Pharmacology, Clinical Pharmacology/Epigenetic

Master In Pharmacology, Lower Urinary Tract Pharmacology

Bachelor Of Pharmacy