Senior Clinical Research Associate (España)

Senior Clinical Research Associate (España)

30 jul
|
Alira Health SLU
|
España

30 jul

Alira Health SLU

España

Overview
Senior Clinical Research Associate (SR CRA) – Spain. The SR CRA is a key member of the Alira Health Clinical team responsible for site monitoring, ensuring compliance and quality of clinical trials. Salary range: €55,000 – €65,000.
Key Responsibilities
- Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
- Review monitoring visit reports and conduct co‑monitoring and evaluation visits as needed.
- Ensure appropriate and timely investigator site visits and assist with study recruitment, site training, and other site‑related issues.
- Coordinate with cross‑functional departments to facilitate negotiation or issue resolution related to clinical trial monitoring.
- Assist in development of study‑specific Monitoring Plans and training presentations.
- Assist in setup and collection of site‑specific ethics documents and site contract negotiation.
- Provide monthly billing information to the finance team.




- Manage study budget and act as referent for the sponsor on stand‑alone monitoring projects.
- Perform qualification, initiation, interim, and close‑out visits both remotely and onsite, documenting site‑related problems, resolutions, actions, protocol deviations, study progress, and enrollment status.
- Ensure integrity of CRF data through thorough source document review and verification.
- Perform quality control and verification of documents collected at sites for eTMF/TMF.
- Conduct investigational product accountability and review site regulatory binder for required documents.
- Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests.
- Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs.
- Participate in internal, client/sponsor, scientific, and other meetings as required.
- Facilitate adverse event reporting and reconcile SAE reports wi

📌 Senior Clinical Research Associate (España)
🏢 Alira Health SLU
📍 España

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