Sr CRA

hace 1 mes

Santiago, Chile Thermo Fisher Scientific A tiempo completo

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.

  • Sr. Cra

    hace 3 días

    Santiago de Chile MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...

  • Sr Cra

    hace 3 semanas

    Santiago de Chile Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Sr CRA

    hace 1 semana

    Santiago, Chile Thermo Fisher Scientific A tiempo completo

    Job DescriptionMonitors 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...

  • Sr Cra

    hace 1 mes

    Santiago de Chile Thermo Fisher Scientific A tiempo completo

    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...

  • Sr CRA

    hace 2 semanas

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    Job Description: As a Monitoring Specialist, you will be responsible for overseeing investigator sites using a risk-based monitoring approach. You will utilize root cause analysis, critical thinking, and problem-solving skills to identify and address site process failures. Your main goal is to ensure compliance, reduce risks, and maintain data accuracy...

  • Sr CRA

    hace 1 mes

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    Job Description: As a Monitoring Specialist, you will be responsible for overseeing investigator sites using a risk-based monitoring approach. You will utilize root cause analysis, critical thinking, and problem-solving skills to identify and address site process failures. Your main goal is to ensure compliance, reduce risks, and maintain data accuracy...

  • Cfsp Sr Cra 1

    hace 1 semana

    Santiago de Chile Novasyte A tiempo completo

    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 Clinical Trial Coordinator

    hace 3 semanas

    Santiago de Chile MSD A tiempo completo

    **Job Description**: Bajo la supervisión del gerente de línea, esta personal es responsable de las actividades financieras integrales de estudio y sitio. El rol es fundamental para cumplir con las fechas planificadas de Start-up del sitio, la negociaciones del contrato. La función colaborará a nível local estrechamente con COM, CRM y CRA. **Colaborará...

  • Sr Clinical Trial Coordinator

    hace 2 semanas

    Santiago, Metropolitana, Chile MSD A tiempo completo

    Job Description:Bajo la supervisión del gerente de línea, esta personal es responsable de las actividades financieras integrales de estudio y sitio.El rol es fundamental para cumplir con las fechas planificadas de Start-up del sitio, la negociaciones del contrato. La función colaborará a nível local estrechamente con COM, CRM y CRA.Colaborará con los...

  • Sr Clinical Research Associate

    hace 4 semanas

    Santiago de Chile MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...

  • Sr Clinical Research Associate

    hace 4 semanas

    Santiago de Chile MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Sr Clinical Trial Coordinator

    hace 2 semanas

    Santiago, Chile CDS Fortrea Inc. A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Operations Manager

    hace 4 semanas

    Santiago de Chile MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance...

  • Clinical Operations Manager

    hace 2 semanas

    Santiago, Metropolitana, Chile MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance...

  • Clinical Operations Manager

    hace 2 semanas

    Santiago, Metropolitana, Chile MSD A tiempo completo

    Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Clinical Operations Manager

    hace 4 semanas

    Santiago, Metropolitana, Chile MSD A tiempo completo

    Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Clinical Operations Manager

    hace 4 semanas

    Santiago, Chile MSD A tiempo completo

    Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...