Es posible que un gran número de candidatos se presenten a este puesto, así que asegúrese de enviar su CV y su solicitud lo antes posible.
The Senior Clinical Research Associate (Sr CRA) is a key member of the Alira Health Clinical team. The Sr CRA independently conducts site monitoring activities, oversees clinical trial execution, and ensures protocol compliance and quality throughout the study life cycle.
Responsibilities
-
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
- Reviews monitoring visit reports, conducts co‑monitoring and evaluation visits as needed.
- Ensures appropriate and timely investigator site visits.
- Coordinates with cross‑functional departments to facilitate negotiation and issue resolution for monitoring related issues.
- Assists in development of study‑specific monitoring plans and training presentations.
- Assists in set up/collection of site‑specific ethics documents and site contract negotiation.
- Provides monthly billing information to finance team.
- For monitoring stand‑alone projects, manages study budget and acts as referent for the sponsor.
- Performs qualification, initiation, interim, and close‑out visits both remotely and onsite, ensuring proper documentation.
- Prepares accurate monitoring visit reports documenting site‑related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
- Ensures integrity of CRF data through meticulous source document review and verification.
- Conducts quality control and verification of documents collected at sites for eTMF/TMF.
- Conducts investigational product accountability.
- Reviews site regulatory binder for required documents.
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
- Complies with ICH GCP guidelines, FDA regulations, and company/spo
📌 Senior Clinical Research Associate (Barcelona)
🏢 Alira Health
📍 Barcelona
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.