Contractor Cra_Spain

Tigermed; Las Palmas de Gran Canaria; Presencial; EUR 32.000 - 45.000; Jornada completa

Descripción de la vacante

Tigermed, contratista CRA en Las Palmas de Gran Canaria, busca un/a CRA senior para supervisar la selección de sitios, la iniciación (SIV) y la monitorización clínica. Se requiere experiencia en ICH‑GCP y en operaciones de ensayos, así como capacidad para coordinar visitas y gestionar documentación regulatoria.

Entre tus responsabilidades figuran realizar visitas previas, entrenar al personal del sitio, asegurar la notificación de SAE y mantener archivos de ensayo y sistemas de gestión; también

Formación

• Bachelor degree or above in Medical, Pharmacology or Biology related major.
• At least 8 year of CRA experience;
• Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures.
• Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsabilidades

• Study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
• Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
• Ensure PI/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
• Track study recruitment to ensure recruitment target is achieved in all studies.
• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
• Assemble site specific EC submission dossier, and ensure submission to EC.
• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.
• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.
• Prepare/complete study records' archiving according to protocol and sponsor requirements.
• Ensure safety information is disseminated to all sites according SOP and applicable regulations.
• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
• Finalize budget and obtain signed contract from site, prior to site initiation visit.
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
• Update and maintain Study tools/systems in a timely manner.

Conocimientos

CRA experience

GCP knowledge

MS Office

Site initiation

Coordination

Educación

Bachelor degree or above in Medical/Pharmacology/Biology

Herramientas

Microsoft Word/Excel/PPT

Descripción del empleo

Contractor CRA_Spain Tigermed Las Palmas de Gran Canaria, canary islands, Spain

Descripción del trabajo

Responsibilities

• Study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
• Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
• Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
• Track study recruitment to ensure recruitment target is achieved in all studies.
• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
• Assemble site specific EC submission dossier, and ensure submission to EC.

Training

• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.
• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.
• Prepare/complete study records' archiving according to protocol and sponsor requirements.

(b) Drug Safety

• Ensure safety information is disseminated to all sites according SOP and applicable regulations.
• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

• Finalize budget and obtain signed contract from site, prior to site initiation visit.
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

• Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major.

3.2 At least 8 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.