Clinical Research Associate II

PSI CRO·Madrid, Spain

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About the role

Hybrid, permanent full-time Clinical Research Associate II role in Madrid, Spain. Responsibilities include onsite monitoring visits, CRF review, source document verification, query resolution, site management, feasibility research, regulatory submission support, and audit preparation. Requires Life Sciences and Clinical Trials degrees, at least one year of independent onsite monitoring experience in Spain, Phase II/III monitoring experience, English and Spanish proficiency, MS Office skills, and travel ability.

Key requirements

• A degree in Life Sciences and a Master’s degree in Clinical Trials are required
• At least 1 year of relevant experience
• Required skills: Independent on-site monitoring experience in Spain, Experience with SIV, RMV and COV monitoring visits, Experience in Phase II and/or III trials, Clinical site communication and management, CRF review, Source document verification, Query resolution, Regulatory submission support, Feasibility research, Audit and inspection preparation, MS Office proficiency, Planning and multitasking, Communication, Collaboration, Problem-solving, Ability to travel
• Required languages: English, Spanish

Opportunity details

• Workplace: Hybrid
• Employment: Permanent
• Posted: Sep 30, 2026
• Original advert language: English

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Job title: Clinical Research Associate II

Location: Madrid, MD, Spain

Employment type: Full-time

Workplace type: Hybrid

Company Description

PSI is a leading Contract Research Organisation with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.

You will:

Conduct and report SIV, RMV, COV onsite monitoring visits
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Be a point of contact for in-house support services and vendors
Communicate with internal project teams regarding study progress
Participate in feasibility research
Support regulatory team in preparing documents for study submissions
Prepare and participate on audits and inspections

Qualifications

A degree in Life Sciences and a Master’s degree in Clinical Trials are required
At least 1 year of independent on-site monitoring experience in Spain
Experience in all types of monitoring visits in Phase II and/or III
Full working proficiency in English and Spanish
Proficiency in MS Office applications
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel

Additional Information

What We Offer:

Stability, long-term cooperation
Permanent contract, full-time job
Competitive salary and benefit package
Career development
Unique combination of team collaboration and independent work
Friendly and supportive colleagues
Onboarding courses about clinical research industry
Comfortable and well-established office

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.