Keli Balduino Email & Phone Number

Montreal, Quebec, Canada

• Responsible for study design for clinical and non clinical pharmacokinetic/bioequivalence studies.• Responsible for the scientist assessment of projects including risk assessment analysis, costs and timelines and prepare a technical document support approval for early stage pipeline project approval.• Responsible to stablish study timeline with study site according to internal priorities and ensure adherence to study timeline.• Ensure good conduct of study and take care of issues raised by the clinical site/CRO regarding timelines, monitoring corrective action, protocol deviation and other clinical issues.• Perform literature, clinical and non clinical data searches /reviews as necessary to obtain background information for review and preparation of study-related documents.• Execute pharmacokinetic/pharmacodynamic analyses of clinical study data and non clinical data, perform compartmental and non compartmental analysis using winNonlin.• Provide justification and prepare written technical documents for queries to health authorities.• Prepare written responses to regulatory authorities ‘clarifaxes and deficiency letters.• Contribute scientific support to other departments and colleagues.• Perform quality control review of analysis/documents prepared by other scientists. • Work closely with Project Management and Regulatory Affairs.• Prioritize own work and manage projects schedule to meet delivery deadlines.• Responsible for negotiating the price and for outsourcing of bioequivalence studies]

Montreal, Quebec, Canada

• Protocol review to assure that it is according to GCP/ICH regulation.• Assure that protocol is been conduct accordingly with GCP.• Follow closely IRB submission to answer promptly any question/query on clinical operation related, permitting protocol be approved following the study schedule.• Subject payment plan.• Planning, lead and the execution of clinical trials phase 1 and bioequivalence.• Oversight and lead the team to conduct the study and delivery quality study data.• Assure that the protocol is been conducted accordingly with sponsor's exigences, protocol and following SOPs.

Montreal, Quebec, Canada

• Assure client data confidentiality, according to Canadian regulation.• Perform information gathering & prescription data entry.• Guarantee a good client experience. • Medication dispensing.

Montreal, Quebec, Canada

Experience as a volunteer in some institutions, working with customer service and general services, inthe company "Manoir Ronald Mc Donalds, patient reception in the flu vaccination period (2019/2020),event reception in English and French.

São Paulo E Região, Brasil

• Manage and supervise regulatory submission to IRB to guarantee follow the study schedule. Assure the submissions was done according with ethical regulation, institutional and national requirements.• Manage and supervise final report to ethical submission.• Manage and supervise Serious adverse events submission to sponsor and local IRB, follow ethic and sponsor regulation.• Perform contract negotiation and elaboration, assuring follow regulations for Sponsor, institution and any third part involved on study, as well according with law and ethic regulation.• Negotiate and review study budget. • Review and supervise feasibility completion, SIV, site qualification, on study monitoring and close out visit.• Clinical trials records management.Planning, managing and supervising the execution of clinical trials. • Manage and supervise subject recruitment.• Observational and interventional (phases 3 and 4) Clinical Trials Management, in several areas.• Conception and organization of events, workshops, webinars, courses and staff training.• Concept and review of work tools, worksheets, SOPs and questionnaires development.

Brazil

• Client prospection, partnerships prospections.• Clients relationship and support.• Company website, documents and didactic material translate.• Educational platform operation and material didactic development.

São Paulo E Região, Brasil

• Perform regulatory submission to local IRB, for study approval as well the final report.• Assure all SAE submission was done according to ethic regulation, sponsor and national guidelines.• Assure patient recruitment and randomization according with the number give on feasibility document.• Knowledge on Clinical Trials regulatory regulation, Good Clinical Practice and International regulation.• Development of work tools and worksheets.• Clinical Trial Site structuration, pneumology area, permitting clinical trials be conducted in a relevant institution without a clinical research site centralized. • Phase 2 and 3 study coordination in pneumology, pediatric and oncology.• Internship supervisor and monograph examiner.• SOPs elaboration and revision.• Fill Clinical Research form, IVRS system, electronic diary.

• Reserch project development.• Protein expression in E. Coli.• Protein refolding and purification.• Daily routine in microbiology protocols.• Phisic-chemistry analisys, soltutions preparations.

Rio Claro Area, Brazil

• Reserch project development.• Daily routine in microbiology protocols.• Protein expression in fungus.• Phisic-chemistry analisys, soltutions preparations.

Campinas, São Paulo, Brazil

• Analyse de pesticide en échantillons alimentaires.• Activités quotidiennes du laboratoire.• Analyse physico-chimique.

Master'S Degree, Biotechnology

Dep, Paharmacy Technician

Clinical Research

Bachelor'S Degree, Biology, General, Undergraduation

English Proficiency, English Language And Literature, General

French Studies

Technician, Food Technology And Processing