Contractor Cra_Spain

Tigermed; Málaga; Presencial; EUR 42.000 - 65.000; Jornada completa

Descripción de la vacante

Tigermed busca un/a profesional CRA con experiencia para supervisar selección y monitoreo de sitios, entrenamiento SIV y cumplimiento normativo según ICH-GCP.

La función implica gestionar seguridad, informes SAE, coordinación de materiales y mantenimiento de archivos del estudio. Se valorará dominio de MS Office y experiencia en operaciones de ensayos clínicos.

Formación

• Conocimiento de buenas prácticas clínicas (GCP) y operativa de ensayos clínicos.
• T degree en Medicina, Farmacología o Biología o similar.
• Dominio de herramientas de MS Office para gestión de documentos.

Responsabilidades

• Monitoreo y selección de sitios conforme criterios de estudio.
• Conducir SIV para entrenamiento de personal del sitio.
• Asegurar cumplimiento de seguridad y reportes SAE.
• Gestionar materiales del estudio y coordinación entre sitios.
• Mantener archivos de ensayo y regulatorios actualizados.

Conocimientos

GCP knowledge

Clinical trial operations

Educación

Bachelor degree in Medical/Pharmacology/Biology

Herramientas

Microsoft Word

Excel

PowerPoint

Outlook

Descripción del empleo

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.