Clinical Regulatory Analyst

hace 4 días

Buenos Aires, Argentina 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 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**:

- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- 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.

  • Clinical Validation Analyst

    hace 3 días

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Argentina - Home Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Validation Analyst to join our diverse...

  • Sr Clinical Datavalidation Analyst

    hace 4 días

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Argentina. Home based. ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Validation Analyst to join our...

  • Regulatory Analyst

    hace 1 semana

    Buenos Aires, Argentina UPL ltd A tiempo completo

    **Regulatory Analyst**: - Job Id: 7618- City: 06503, Buenos Aires, Argentina- Department: - Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Not Applicable- Description: - Analista de Regulatorio

  • Regulatory Analyst

    hace 3 días

    Buenos Aires, Argentina The Gowan Co. A tiempo completo

    **Regulatory Analyst** **Position Summary**: The Regulatory Analyst supports the Regional Regulatory Manager in overseeing product registrations, ensuring compliance with regulatory standards, and facilitating the approval process for new and existing products. The role involves detailed analysis, coordination with internal teams, and the preparation of...

  • Clinical Data Risk Analyst

    hace 3 semanas

    Buenos Aires, Argentina ICON A tiempo completo

    Clinical Data Risk Analyst - Remote - Argentina ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Data Risk...

  • Clinical Data Risk Analyst

    hace 3 semanas

    Buenos Aires, Argentina ICON A tiempo completo

    Clinical Data Risk Analyst - Remote - Argentina ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Data Risk...

  • Senior Clinical Validation Analyst

    hace 3 semanas

    Buenos Aires, Argentina ICON A tiempo completo

    Senior CVA, Chennai, Office based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Validation Analyst to...

  • Clinical Data Risk Analyst

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina IRE A tiempo completo

    Clinical Data Risk Analyst - Remote - ArgentinaICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Clinical Data Risk Analyst...

  • Clinical Data Risk Analyst

    hace 4 días

    Buenos Aires, Buenos Aires C.F., Argentina ICON plc A tiempo completo

    Clinical Data Risk Analyst - Remote - ArgentinaICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Clinical Data Risk Analyst...

  • Regulatory Affairs Associate

    hace 5 días

    Buenos Aires, Argentina Parexel A tiempo completo

    A health improvement company seeks individuals passionate about enhancing global health through clinical trials and regulatory consulting. Ideal candidates should possess strong proofreading, writing, and analytical skills. Experience in FDA regulations and biotechnology is essential. Join a team dedicated to delivering impactful solutions that contribute...