Senior Clinical Research Associate
Hace 2 semanas
Sevilla, Andalucía, España
Precision Medicine Group
Jornada completa
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Overview Senior CRAs in Spain join an evergreen talent pipeline to support a strategic sponsor in a collaborative, quality-driven environment. You will monitor studies, ensure compliant conduct, and work across cross-functional teams from site setup to study closeout. The role offers home-based flexibility and opportunities to mentor junior staff and engage directly with clients. This is a high-impact position focused on delivering quality clinical data and supporting complex, multi-country trials. Responsabilidades
* Monitor progress of clinical studies at investigative sites to ensure adherence to protocol, SOPs, ICH-GCP, and regulations
* Coordinate study setup and monitoring activities: identify investigators, regulatory submissions, pre-study and initiation visits
* Support trials of varying scope within a CRO/pharma environment, including larger studies
* Train and mentor junior staff members
* Interact with clients, initiate payments, and contribute to proposal development and client presentations Requisitos principales
* Minimum 5 years of CRA/ SCR A experience in CRO, pharmaceutical, biotechnology, or medical device environment
* Experience in IVD, oncology, infectious diseases, and gastrointestinal studies
* Proven multi-country monitoring experience in Europe (Germany, France, UK, Denmark)
* Domestic travel up to 50–60% (international travel may be required for some roles)
* Fluency in Spanish and English; additional languages a plus
* Holder of CRA certificate
* 4-year college degree or equivalent
* calm and thoughtful under pressure
* strong preparation and proactive planning
* attention to detail
* ICH-GCP compliance
* regulatory submissions coordination
* site monitoring and study management
* Monitor progress of clinical studies at investigative sites to ensure adherence to protocol, SOPs, ICH-GCP, and regulations
* Coordinate study setup and monitoring activities: identify investigators, regulatory submissions, pre-study and initiation visits
* Support trials of varying scope within a CRO/pharma environment, including larger studies
* Train and mentor junior staff members
* Interact with clients, initiate payments, and contribute to proposal development and client presentations Requisitos principales
* Minimum 5 years of CRA/ SCR A experience in CRO, pharmaceutical, biotechnology, or medical device environment
* Experience in IVD, oncology, infectious diseases, and gastrointestinal studies
* Proven multi-country monitoring experience in Europe (Germany, France, UK, Denmark)
* Domestic travel up to 50–60% (international travel may be required for some roles)
* Fluency in Spanish and English; additional languages a plus
* Holder of CRA certificate
* 4-year college degree or equivalent
* calm and thoughtful under pressure
* strong preparation and proactive planning
* attention to detail
* ICH-GCP compliance
* regulatory submissions coordination
* site monitoring and study management