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.

Resolve queries on discrepant data in coordination with in‑house CRAs, CTC, and data management.

Proactively identify site issues and develop problem‑solving strategies.

Conduct audit preparation at study sites as needed.

Collaborate with other CRAs to maintain consistency and promote a collaborative team atmosphere.

Assist in CRA new hire training, onboarding, and mentoring.

Collaborate in development and maintenance of the Clinical Trial Management System (CTMS).

Manage and resolve conflicting priorities to deliver on commitments.

Perform additional duties as assigned.

Desired Qualifications & Experience

US: BS/BA in a life sciences or related discipline.

US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience, and 1 year of management experience.

EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and the ability to autonomously manage monitoring activities.

Technical Competences & Soft Skills

Quality focused; detail‑oriented and thorough.

Strong organizational and multi‑tasking skills; ability to work effectively in a fast‑paced environment.

Ability to manage priorities, organize time, and solve problems.

Strong analytical, negotiation, meeting management, cross‑functional team, and leadership skills.

Ability to travel and manage stress.

Professional, trustworthy, and disciplined.

Problem‑solving unstructured or ambiguous challenges.

Strong command of English (US); local language (EU) and local regulations knowledge.

Excellent communication and interpersonal skills with customer service orientation.

Computer skills; ability to use CTMS, clinical trial databases, and electronic data capture.

Self‑starter in a collaborative but less structured team environment.

Knowledge of clinical research, ICH GCP, local regulations, and regulatory and ethical requirements.

Ability to establish and maintain positive relationships with sponsor, site, and project team members.

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