Cfsp Cra 1

hace 4 semanas

Ciudad de México Novasyte A tiempo completo

Job OverviewPerform 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 with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.- Collaborate and liaise with study team members for project execution support as appropriate.- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.**Qualifications**:- High School Diploma or equivalent Degree in scientific discipline or health care preferred.- 6 months of experience on site monitoring OR 3 years of experience as a Study Coordinator.- Some organizations require completion of CRA training program or prior monitoring experience.- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).- Good therapeutic and protocol knowledge as provided in company training.- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).- Written and verbal communication skills including good command of English language.- Organizational and problem-solving skills.- Effective time and financial management skills.- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • cra 1

    hace 13 horas

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform 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 with...

  • Cfsp Cra 2

    hace 6 días

    Ciudad de México Novasyte A tiempo completo

    Job OverviewPerform 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 with...

  • Cra 2

    hace 4 semanas

    Ciudad de México IQVIA A tiempo completo

    **Join IQVIA as a Clinical Research Associate 2 (CRA 2)****Location**: Mexico City, Guadalajara or Monterrey**About the role**:At IQVIA, we’re reshaping the future of healthcare through innovation and data-driven insights. As a Clinical Research Associate (CRA), you’ll be at the forefront of clinical excellence—ensuring that investigational sites...

  • Cra 2

    hace 4 días

    Ciudad de México IQVIA A tiempo completo

    **Join IQVIA as a Clinical Research Associate 2 (CRA 2)** **Location**: Mexico City **About the role**:At IQVIA, we’re reshaping the future of healthcare through innovation and data-driven insights. As a Clinical Research Associate (CRA), you’ll be at the forefront of clinical excellence—ensuring that investigational sites conduct studies with...

  • Cra 2

    hace 8 horas

    Ciudad de México IQVIA A tiempo completo

    **Join IQVIA as a Clinical Research Associate 2 (CRA 2)** **Location**: Mexico City, Guadalajara or Monterrey **About the role**:At IQVIA, we’re reshaping the future of healthcare through innovation and data-driven insights. As a Clinical Research Associate (CRA), you’ll be at the forefront of clinical excellence—ensuring that investigational sites...

  • Cra Ii

    hace 2 semanas

    Ciudad de México Fortrea A tiempo completo

    **Summary of Responsibilities**: - Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. - Conducts site monitoring responsibilities for clinical trials according to Fortrea’s...

  • Cra Ii

    hace 1 semana

    Ciudad de México Fortrea A tiempo completo

    **Summary of Responsibilities**:- Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.- Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard...

  • Cra 1

    hace 2 semanas

    Ciudad de México IQVIA 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...

  • Sr Cra 1

    hace 7 días

    Ciudad de México 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...

  • Cra Ii

    hace 7 días

    Colonia Lomas de Chapultepec, México Labcorp A tiempo completo

    The Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project...