Senior Clinical Research Associate role at a general CRO supporting oncology and neuroscience clinical trials across Spain. The position involves full site monitoring lifecycle management, protocol compliance oversight, data integrity protection, and mentoring of junior CRAs on global studies. Responsibilities Lead site qualification, initiation, interim monitoring, management, and close-out while ensuring GCP and regulatory compliance Perform source document verification, review informed consent forms, and conduct safety data reviews to protect patient safety Guide sites on protocol adherence, investigator file maintenance, and investigational product accountability Mentor junior CRAs, conduct accompanied site visits, and provide training to less experienced colleagues Develop monitoring plans, templates,



and training materials; review site visit reports with constructive feedback Requirements MD or pharmacy qualification (PharmD, MSPH, PhD, or equivalent) with minimum 3 years CRA experience Alternatively: four-year science degree with minimum 5 years CRA experience Alternatively: two-year college/nursing degree or equivalent with minimum 7 years CRA experience Thorough knowledge of FDA/EU regulations, ICH Guidelines, and clinical research principles Expertise in two to three therapeutic areas sufficient to lead monitoring activities Proficiency in Microsoft Office, IxRS, and electronic data capture systems Valid passport and driving license; fluency in Spanish and English

📌 Senior Clinical Research Associate (España)
🏢 Worldwide Clinical Trials
📍 España