Fernanda Kuhn Email & Phone Number

Porto Alegre, Rs, Br

Porto Alegre, Rio Grande Do Sul, Brasil

Rio Grande Do Sul, Brasil

• Ensure clinical trials conducted under the responsibility of RARAS CRO are performed according the ICH- GCP guidelines, the local and international regulations as well as according to RARAS CRO or sponsor SOPs.• Ensure clinical trial data are accurate and verifiable, identifying and carrying out the corresponding quality controls on source documents.• Act as the main contact of clinical trial for investigative sites.

Porto Alegre, Rio Grande Do Sul, Brasil

● Being responsible for clinical trials data entry in EDC systems (Rave, InForm); ● Guaranteeing data quality through the revision of the source document, checking if they are in accordance with the study protocol and with the Good Clinical Practices, and if necessary requesting the pertinent corrections; ● Applying administrative and behavior surveys in study subjects.Main achievements: Efficiency of EDC data insert has been increased, metrics has been improvement and maintenance of deadlines. Review and quality of data in medical charts has been done helping to reduce the number of monitoring findings. Operational procedures have been developed and reviewed, conducts and standards have been set in the activities performed by the clinical research team based on specific regulations and protocols, aiming at greater efficiency in procedures and data quality.

Porto Alegre E Região, Brasil

● Clinical trials in oncology-mastology phase II and III were conducted and coordinated according to the protocol, followed the GCP and other guidelines; ● Health team involving 6 direct and 2 indirect staffs were coordinated and encouraged to grow through constant feedback;● Trains were conducted aiming to upgrade and guide site team in the activities of each study, ensuring the GCP was followed in the processes;● Regulatory documents were prepared and submitted to CEP and through Plataforma Brasil to CONEP;● New workflows were implemented to improve Data quality and team adherence to the GCP;● Necessary corrections were requested to the clinical team, ensuring the data would be in accordance with the protocol, GCP and relevant legislation;● Monitoring visits were accomplished, providing necessary documents, making corrections, resolving the finding and helping the CRAs.● Files and documents of the study were kept updated and complete, making them available for the Sponsor, the CRO and the staffs whenever requested;● Tools such as flowcharts and templates were prepared and developed in order to facilitate the workflow and to improve the data quality;Main achievements: New workflows were implemented to improve the data quality and data entry in EDCs in an effective and contemporaneous way, thus reducing data issues and monitoring findings. New staff was hired to support the new flows, both for the medical team and for assisting the data insertion, scheduled appointments and exams. A new attendance room was implemented to optimize and improve the medical attendance, aiming the participant’s well-being.

Novo Hamburgo E Região, Brasil

● Regulatory documents were prepared and submited to CEP and to CONEP (through Plataforma Brasil); ● Strategies were developed to recrute resarch subjects, giving support to the medical team in the selection of the participants;● Hospital staffs and outsouced services envolved at the protocol procedures were oriented, seeking to establish processes and to train the team;● Contact with the Hospital administration was maintained and respected by the Hospital team, to ensure the processes, flows and quality required by the research;● Contact with subjects was done, in order to orientate about the studies procedures;● Exams and procedures were scheduled to subjects, thus ensuring that the protocols procedures were being respected;● Assistance to the Principal Investigator in made decisions on value and clauses was given, based on the analysis of the studies budgets and contracts;● Biological samples were managed, prepared and sent, following the IATA instructions and training. Main achievements: SOPs were development and implemented, following the regulatories guidelines, relevant legislation and GCP. New tools and templates were developed, aiming the improvement of data capture, studies procedures, thus guaranteeing their quality; The teams (Hospital, Site and outsources) were trained at procedures and flows, involving the clinical trials subjects, ensuring the data quality and aplication of GCP in the exercise of their functions.

Master'S Degree - Msc, Zoology/Animal Biology, A

Activities and Societies: seminars - article discussion - classroom activities• A research project is Ichthyology area was developed; •.

Exchange Program

● Int. teacher education studies: Educational Science: Theory Course ● Biodiversity

Bacherol Degree'S, Biological Sciences