[Z-25] | Contract- Sr. Cra, Oncology (Mexico) - Iqvia Biotech

[Z-25] | Contract- Sr. Cra, Oncology (Mexico) - Iqvia Biotech

23 may
|
Empresa reconocida
|
Temixco

23 may

Empresa reconocida

Temixco

Descripción:



POSITION TITLE:Senior Clinical Research Associate (CRA)

REPORTS TO:Director/Associate Director, Clinical Monitoring (US) or Designee

CRA Manager (EU) or Designee

BASIC FUNCTIONS:

Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.



ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

Trains site staff on the EDC system and verifies site computer system.

Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

Assists with, and attends, Investigator Meetings for assigned studies.

Authorized to request site audits due to data integrity concerns.

Attends study-related, company, departmental, and external meetings, as required.

Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

Ensures all study deliverables are completed per IQVIA Biotech and study timelines

Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

Serves as mentor for junior CRAs and those new to the company and/or study.

Performs other duties, as requested.



LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

The Lead Clinical Research Associatemayperform any of the following tasks:

Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

Assists with, and attends, Investigator Meetings for assigned studies.

Train site staff on the EDC system and verify site computer system.

Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

Assist the study management in identifying and generating changes in scope

Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

Authorized to request site audits due to data integrity concerns.

Attends study-related, company, departmental, and external meetings, as required.

Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

Ensure all study deliverables are completed per IQVIA Biotech and study timelines

May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

Serve as mentor for junior CRAs and those new to the company and/or study.

Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

Review and approve CRA travel expenses and time sheets.

Perform other duties, as requested.



#LI-SA3

#LI-Remote

#CRAIBAJD

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at .

hace 19 horas

report

Reportar este trabajo

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.com.mx/empleo/17667167/z-25-contract-cra-oncology-mexico-iqvia-biotech-temixco/?utm_source=html

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:
Escribe tu dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: [z-25] | contract- sr. cra, oncology (mexico) - iqvia biotech
Publica un nuevo anuncio gratuito
Necesitas publicar un anuncio? Con más de 1 millón de usuarios únicos al mes en corto encontrarás el candidato ideal para tu empresa, ¿qué estás esperando!
Publica ahora

Suscribete a esta alerta