Sr CRA

3 semanas atrás


São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

Essential Functions

 Monitors investigator sites with a risk-based monitoring approach: applies root 
cause analysis (RCA), critical thinking and problem-solving skills to identify site 
processes failure and corrective/preventive actions to bring the site into 
compliance and decrease risks. Ensures data accuracy through SDR, SDV and 
CRF review as applicable through on-site and remote monitoring activities. 
Assess investigational product through physical inventory and records review. 
Documents observations in reports and letters in a timely manner using 
approved business writing standards. Escalates observed deficiencies and issues 
to clinical management expeditiously and follow all issues through to resolution. 
May need to maintain regular contact between monitoring visits with 
investigative sites to confirm that the protocol is being followed, that previously 
identified issues are being resolved and that the data is being recorded in a 
timely manner. Conducts monitoring tasks in accordance with the approved 
monitoring plan. Participates in the investigator payment process. Ensures a 
shared responsibility with other project team members on issues/findings 
resolution. Investigates and follows-up on findings as pplicable 
 Provides trial status tracking and progress update reports to the Clinical Team 
Manager (CTM) as required. Ensures study systems are updated per agreed 
study conventions ( Clinical Trial Management System, CTMS). Performs QC 
check of reports generated from CTMS system where required.
 Participates in investigator meetings as necessary. Identifies potential 
investigators in collaboration with the client company to ensure the acceptability 
of qualified investigative sites. Initiates clinical trial sites according to the 
relevant procedures to ensure compliance with the protocol and regulatory and 
ICH GCP obligations, making recommendations where warranted. Ensures trial 
close out and retrieval of trial materials.
 Ensures that required essential documents are complete and in place, according 
to ICH-GCP and applicable regulations. Conducts on-site file reviews as per 
project specifications. 
 Contributes to the project team by assisting in preparation of project 
publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM ( trip report review, newsletter 
creation, lead CRA team calls etc).
 Facilitates effective communication between investigative sites, the client 
company and the PPD project team through written, oral and/or electronic 
contacts.
 Responds to company, client and applicable regulatory 
requirements/audits/inspections.
 Maintains & completes administrative tasks such as expense reports and 
timesheets in a timely manner.
 Contributes to other project work and initiatives for process improvement, as 
required.


  • Cra Line Manager Sr

    2 meses atrás


    Sao Paulo, Brasil Novo Nordisk Tempo inteiro

    CRA Line Manager Sr. **Category**:Clinical Development**Location**:São Paulo, São Paulo, BR- Seize the opportunity to shape your career with Novo Nordisk! We're on the lookout for a dynamic Clinical Research Associate (CRA) Line Manager Sr. to lead our expanding Clinical Trials division. In this pivotal role, you will take charge of a team of internal and...

  • Sr Cra

    3 semanas atrás


    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global...

  • Sr Cra

    2 semanas atrás


    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Sr Cra

    1 semana atrás


    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global...

  • Sr CRA

    3 semanas atrás


    São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Essential Functions  Monitors investigator sites with a risk-based monitoring approach: applies root  cause analysis (RCA), critical thinking and problem-solving skills to identify site  processes failure and corrective/preventive actions to bring the site into  compliance and decrease risks. Ensures data accuracy through SDR, SDV and  CRF review...

  • Sr Cra

    3 semanas atrás


    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Essential Functions Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable...

  • Sr CRA 1

    Há 1 mês


    São Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Sr CRA 1

    Há 1 mês


    São Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...

  • Sr CRA 1

    Há 5 dias


    São Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Sr Cra 1

    2 meses atrás


    Sao Paulo, Brasil Novasyte Tempo inteiro

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Sr Cra 1

    Há 5 dias


    Sao Paulo, Brasil Novasyte Tempo inteiro

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Sr. Cra I

    2 meses atrás


    Sao Paulo, Brasil Fortrea Tempo inteiro

    Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion,...

  • Sr Cra

    1 semana atrás


    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes...

  • Sr Cra

    2 meses atrás


    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    **Summarized Purpose

  • J&f Investimentos

    2 meses atrás


    Sao Paulo, Brasil J&F Investimentos Tempo inteiro

    Estamos com uma oportunidade para Analista Financeiro Sr na J&F Investimentos, esse profissional tem como missão acompanhar todos os processos de Tesouraria, inclusive Fundos de Investimentos, movimentações de Ações, revisão e acompanhamento de cálculos de créditos bancários. Ter bom relacionamento com bancos e clientes internos. Gerar oportunidade...


  • São Paulo, Brasil Genial Investimentos Tempo inteiro

    JOB DESCRIPTION Buscamos profissionais que tenham vontade de crescer, colocar a mão na massa e fazer acontecer. Vivemos um momento único, recheado de desafios e oportunidades para agregar ainda mais valor aos nossos clientes. Se você tem esse perfil e essa ambição, inscreva-se nesta vaga e junte-se a nós para construir o futuro do mercado financeiro. ...


  • São Paulo, Brasil Genial Investimentos Tempo inteiro

    JOB DESCRIPTION Buscamos profissionais que tenham vontade de crescer, colocar a mão na massa e fazer acontecer. Vivemos um momento único, recheado de desafios e oportunidades para agregar ainda mais valor aos nossos clientes. Se você tem esse perfil e essa ambição, inscreva-se nesta vaga e junte-se a nós para construir o futuro do mercado financeiro. ...


  • São Paulo, Brasil IQVIA Tempo inteiro

    Job Overview A Central Monitor is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. Provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts. Essential Functions: Perform centralized monitoring...

  • Sales Operations Sr. Analyst

    4 semanas atrás


    São Paulo, Brasil Kanastra Tempo inteiro

    A Kanastra é o backoffice tecnológico para investimentos alternativos. Somos uma fintech que oferece uma plataforma all-in-one para originadores e investidores no Brasil, fornecendo serviços como gestão e administração de fundos, securitização e serviços bancários para veículos de investimento como FIDCs, FIPs, CRIs, CRAs, CRs, CCBs e notas...

  • Sales Operations Sr. Analyst

    2 semanas atrás


    São Paulo, Brasil Kanastra Tempo inteiro

    A Kanastra é o backoffice tecnológico para investimentos alternativos. Somos uma fintech que oferece uma plataforma all-in-one para originadores e investidores no Brasil, fornecendo serviços como gestão e administração de fundos, securitização e serviços bancários para veículos de investimento como FIDCs, FIPs, CRIs, CRAs, CRs, CCBs e notas...