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Precision for Medicine is a clinical research organization (CRO) specializing in precision medicine and oncology. They are seeking a Clinical Research Associate II to join their team based in Madrid or Barcelona, Spain.
In this role, you will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported in accordance with protocol, SOPs, ICH-GCP guidelines, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor studies, including identifying investigators, preparing regulatory submissions, conducting pre-study and initiation visits, and managing ongoing site relationships.
Key responsibilities include identifying potential study risks and proposing mitigation strategies, maintaining meticulous attention to detail in study documentation, managing conflict resolution with investigators and study teams, and staying ahead of project timelines. You will work with a smaller CRO structure that emphasizes lower protocol loads per associate, enabling you to become a protocol expert while maintaining reasonable work-life balance.
Required qualifications include a 4-year college degree or equivalent experience, a minimum of 2 years as a CRA in a CRO or pharmaceutical/biotech industry, site management or equivalent clinical research experience, and oncology monitoring experience. You must be fluent in English and Spanish, available for domestic travel (50-60% commitment including overnight stays), and able to reside in Madrid or Barcelona.
Preferred qualifications include a graduate or postgraduate degree in a scientific or healthcare discipline, Phase I trial experience, and experience managing CAR-T or first-in-human (FIH) studies. Precision for Medicine emphasizes culture, high employee retention, direct management support, and employee voice in decision-making.
