Contractor Cra_Spain

Tigermed; Tarragona; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Tigermed busca un Monitor/a Clínico para gestionar la selección de sitios, SIV y la monitorización clínica, asegurando el cumplimiento de protocolo y GCP. Participará en la formación del personal y la coordinación de materiales de estudio.

El candidato debe aportar al menos 8 años de experiencia CRA, amplio conocimiento de ICH-GCP y manejo de Word, Excel, PowerPoint y Outlook. Se valoran competencias en procesos regulatorios y gestión de presupuestos.

Formación

• Bachelor degree or higher in medical, pharmacology or biology.
• At least 8 years CRA experience.
• Strong knowledge of ICH-GCP and trial operations.
• Proficient in Word, Excel, PowerPoint and Outlook.

Responsabilidades

• Study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visits to qualify sites per sponsor criteria.
• Prepare and conduct SIV to train site staff.
• Ensure safety reporting per protocol and ICH-GCP.
• Track recruitment to meet targets.
• Conduct monitoring visits per SDV plan and report.
• Coordinate study materials to sites.
• Assemble site EC submission dossier and submit to EC.

Conocimientos

CRA experience

ICH-GCP knowledge

SOP adherence

GCP knowledge

Educación

Bachelor degree or higher in Medical, Pharmacology or Biology

Herramientas

Microsoft Word

Microsoft Excel

Microsoft 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.