Boston Scientific Clinical Research Associate CRA - Madrid Hybrid 

Spain, Community of Madrid 

418876615

Minimum Spanish & English, German or Italian is a plus.
Salary:Depending on experience, between ~ €40k and ~ €55k gross per year

30th of June, 2025

As an In-house CRA, you will be the key contact for Spanish clinical sites and internal study teams regarding site start-up and regulatory documentation. You’ll coordinate ethics committee submissions, manage regulatory timelines, and ensure Spanish sites are ready to recruit patients on schedule. This role is partly office-based (hybrid) and focuses on start-up and regulatory work not on-site monitoring.

Your day might begin with reviewing study dashboards and checking site activation timelines and submission statuses for your Spanish sites. You could spend your morning preparing a new EC submission package or adapting informed consent forms (ICFs) for specific sites. Later, you might join calls with Clinical Trial Managers and divisional stakeholders to align on start-up progress.

Afternoons typically involve answering queries from sites, liaising with Regulatory Affairs, and updating CTMS and eTMF systems to ensure documentation compliance. You’ll collaborate closely with colleagues across Europe and the US, which may mean occasional late virtual meetings. Everyday blends operational focus, regulatory problem-solving, and cross-functional coordination.

You will lead the end-to-end site start-up process for your assigned studies in Spain, including:

• Preparing, submitting, and following up on EC submissions
• Customizing and negotiating informed consent forms (ICFs)
• Managing essential regulatory documents and investigator files
• Ensuring timely site activation aligned with global study timelines
• Acting as the Spanish expert on local clinical research regulations and ethics processes
• Collaborating closely with Clinical Trial Managers, Regulatory Affairs, and divisional teams
• Tracking progress and maintaining study systems (e.g., Veeva CTMS, eTMF)

We welcome candidates with 1–3 years of experience in clinical research operations or regulatory submissions in Spain. If you are earlier in your career but are trilingual in Spanish, English, and either German or Italian, we strongly encourage you to apply as your language skills will be highly valued and can compensate for less experience. Familiarity with ICH-GCP, GDPR, MDR, and local Spanish clinical trial regulations is important. Experience with CTMS and eTMF systems (such as Veeva or Siebel) is preferred. You are organized, detail-oriented, fluent in Spanish and English, and a proactive team player.

This is a great opportunity to build deep expertise in site start-up and regulatory affairs at a leading medical device company. You’ll work in a hybrid model (partly office-based in Madrid, partly remote), within a highly supportive and international team. You’ll gain exposure to various therapeutic areas and clinical study types, creating an excellent foundation for growth in Global Clinical Operations, Regulatory Affairs, or Clinical Study Management.

If you’re ready to advance your clinical research career and help patients access innovative therapies faster, we encourage you to apply.