Senior Clinical Research Associate

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.