Contractor Cra_Spain

Tigermed; Islas Baleares; Presencial; EUR 52.000 - 70.000; Jornada completa

Descripción de la vacante

Tigermed está buscando un CRA con amplia experiencia para gestionar sitios, iniciar ensayos y realizar monitorización conforme a ICH-GCP. El rol implica coordinar formación y asegurar cumplimiento regulatorio en cada sitio.

El candidato ideal debe tener al menos 8 años de experiencia en CRA, dominio de las normativas ICH-GCP y habilidades avanzadas en MS Office. Se trabajará principalmente en España, con posibles visitas a los sitios de estudio.

Formación

• Titulación mínima: Licenciatura o superior en áreas médicas, farmacología o biología.
• Experiencia como CRA de al menos 8 años.
• Dominio de procesos ICH-GCP y operaciones de ensayos clínicos.
• Conocimientos de MS Office (Word, Excel, PPT, Outlook).

Responsabilidades

• Gestión de sitios y selección de sitios, iniciación (SIV) y monitorización clínica.
• Realización de visitas de monitorización según plan SDV y SOP.
• Asegurar que el PI y el personal cumplan con la seguridad en el informe de SAE.
• Gestionar presupuesto, contratos y pagos de los centros.
• Mantener archivos del estudio y archivar documentos según protocolo y requisitos.

Conocimientos

Site management

SIV initiation

ICH-GCP knowledge

Clinical monitoring

Educación

Bachelor degree in Medical/Pharmacology/Biology

Herramientas

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descripción del empleo

Descripción del trabajo

Responsibilities

(a) Site management

• 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.