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 with source documentation and CRFs
📌 Research Associate (España)
🏢 Alira Health SLU
📍 España