About this role:

The In-House Clinical Research Associate (also known as Trial Operations Clinical Research Associate, T-CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

Driving principles and behaviors for this role are caring, diversity, integral collaboration, high performance, meaningful innovation, winning spirit.

Location: Madrid (preferred), Milan or any BSC hub

This role has a hybrid work model.

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the T-CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards,



and applicable company policies and procedures. Specifically, these activities will include:
- Ethics Committee (EC) submissions and approvals.
- Site informed consent form (ICF) customizations & negotiations.
- Essential regulatory document collection.
- Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.

The T-CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.

Your responsibilities will include:
- Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
- Manage multiple sets of essential regulatory documents across several studies and division portfolios.
- Partner with clinical sites and or Ethics Committees and BSC Legal Departme

📌 In‑House Clinical Research Associate, Italy (España)
🏢 Bostonscientific
📍 España