Regulatory & Start-up Specialist

Hybrid – Madrid) 3 days office-based (MUST) + 2 days (home-based)

Location : Madrid, Spain (Hybrid)

About the Role

We are currently seeking an In-house Clinical Research Associate II to join our client's Global Clinical Operations (GCO) Center of Excellence in Madrid. You will play a critical role in supporting site start-up and clinical trial operations across international studies.

This hybrid position offers the opportunity to work in a high-performing, collaborative, and innovative environment, where you'll engage with cross-functional teams to support the execution of high-quality, patient-focused clinical research.

Key Responsibilities

• Coordinate Ethics Committee (EC) submissions and approvals.
• Manage Informed Consent Form (ICF) customization and negotiation with sites.
• Collect and track essential regulatory documents across multiple studies.
• Partner with regulatory teams for Competent Authority (CA) submissions.
• Support site start-up timelines, tracking investigator readiness and compliance.
• Update systems (CTMS, eTMF) with accurate site-level data and documentation.
• Provide regular updates to clinical leadership on progress, risks, and approvals.
• Support enrollment, site communications, audits, and study close-out activities.
• Ensure compliance with ICH / GCP, MDR, GDPR, and internal SOPs.

What We're Looking For

Minimum Requirements :

Preferred :

Why Join Us?

Interested?

Apply directly through LinkedIn or share your CV with us at We look forward to hearing from you

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