Descripción del Puesto:
Última información laboral de Johnson & Johnson Family of Companies para la posición de Monitor Clinical Trials. If the Monitor Clinical Trials vacante en Ciudad de México coincide con tus calificaciones, envía tu solicitud o currículum directamente a través del portal actualizado de Jobkos.
Ten en cuenta que aplicar a un trabajo puede no ser siempre fácil, ya que los candidatos deben cumplir con ciertos requisitos establecidos por la empresa. Esperamos que esta oportunidad en Johnson & Johnson Family of Companies para la posición de Monitor Clinical Trials se ajuste a tu perfil profesional.
At Johnson & Johnson, the largest healthcare Empresa in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open Puestos at the largest healthcare Empresa in the world. When You Join Johnson & Johnson, Your Sig Move Could Mean Our Sig Breakthrough. MONITOR CLINICAL TRIALS Responsabilities: Acts as primary local Empresa contact for assigned sites for specific trials. May participate in site feasibility and/or pre-trial site assessment visits Attends/participates in investigator meetings as needed. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. LD Version 1.1 dated 02 June 2021 (FINAL) For Internal Use Only 10001467: Specialist 4, Clinical Trial Admin/Oper (PG 26) Page 2 of 3 Arranges for the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures accuracy, validity and completeness of data collected at trial sites Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area zt all times. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team. Attends regularly scheduled team meetings and trainings. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV). Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. Acts as a point of contact in site management practices. Usually assigned as a coach and mentor to a less experienced site manager. Contribute to process improvement and training. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”. This is not an exhaustive, comprehensive listing of **Qualifications** At Johnson & Johnson, the largest healthcare Empresa in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any
Información de la Vacante:
- Empresa: Johnson & Johnson Family of Companies
- Puesto: Monitor Clinical Trials
- Lugar de Trabajo: Ciudad de México
- País: MX
Cómo Enviar tu Postulación:
Después de leer y comprender los criterios y requisitos mínimos explicados en la información del trabajo Monitor Clinical Trials at the office Ciudad de México anterior, completa de inmediato tus archivos de solicitud, como carta de presentación, CV (Hoja de Vida), copia de diploma y otros suplementos. Envía a través del enlace Siguiente Página abajo.
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