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 • 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 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 outros) no Investigator Site File (ISF);• Acompanho visitas de monitoria e resolvo pendências de cartas de acompanhamento (FUP);• Realizo reuniões de acompanhamento (follow-up meetings) com os investigadores principais (PIs). Show less

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 progressive multiple sclerosis;• 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 • 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 progressive multiple sclerosis;• 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 (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;• Control the quantity and expiration date of kits for collection of laboratory tests, requesting new kits to Labcorp as needed;• Temperature control and shelf life of medicines stored in the refrigerator;• Control, preparation and archiving of documents (LEC submissions/approvals, initial protocol and study amendments, monitoring letters, center staff CVs and certificates, equipment calibration certificates, among others) in the Investigator Site File (ISF); • Control and calibration of equipment, requesting quotes from suppliers;• Accompany monitoring visits and resolve actions items (pendencies prepared by the study monitor);• Accompany and plan the visits of the 5 participants included in the study;• Coordinated the qualification of a new MRI equipment, serving as a bridge between the sponsor's team and the team of a partner hospital. Show less

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 • 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 step in the RNA (microRNA) extraction, which resulted in 100% extraction efficiency;• Analyzed quantitative and qualitative data using statistical software (Origin and Graph Pad Prisma);• I prepared abstracts and posters for scientific congresses;• I have written and published 2 scientific articles so far, including a scoping review and an original article;• Led 3 scientific initiation students;• I worked as a trainee professor collaborating with the main professor in 5 disciplines at the Faculty of Pharmaceutical Sciences at Unicamp;• Evaluated scientific papers in Semana Acadêmica de Farmácia at Unicamp;• I prepared presentations/classes for Unicamp pharmacy students. Show less

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 • 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;• Applied and corrected tests. Show less

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 animal model of erectile dysfunction, since it relaxes the CC through a mechanism cGMP dependent;• 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 • 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 animal model of erectile dysfunction, since it relaxes the CC through a mechanism cGMP dependent;• Submitted projects to the institution's Animal Use Ethics Committee;• 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;• Wrote and published a scientific article;• Prepared and presented my master's thesis;• Worked as a trainee professor in the discipline of “Principles of Pharmacology” and as a professor of the I and II Curso de Verão em Farmacologia, at the Faculty of Medical Sciences at Unicamp. Show less

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 • 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 the contracted engineering team;• Controlled temperature, pests (rodents and insects) and company water;• Accompanied inspection visits (VISA and CRF);• Performed administrative activities related to the logistics of pharmaceutical products, such as shipping and receiving goods, issuing invoices and cost control of warehousing activities for customers;• Used WMS and Protheus software;• Trained the company's employees on Good Storage Practices;• Followed publications in the D.O.U, Anvisa and CRF. Show less

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• Performed thin layer chromatography (CCD) analyses;• Performed titration… Show more 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• Performed thin layer chromatography (CCD) analyses;• Performed titration analysis;• Performed spectrometry analysis in UV/Vis and Infrared;• Performed dissolution analysis;• Performed preparation of solutions such as mobile phase, standards and samples for HPLC;• Performed physical tests such as average weight, hardness, friability, disintegration and humidity;• Prepared and reviewed SOPs and analytical validation reports. Show less

Phd In Pharmacology, Clinical Pharmacology/Epigenetic

Master In Pharmacology, Lower Urinary Tract Pharmacology

Bachelor Of Pharmacy