CRA II_Barcelona_Sponsor dedicated. Experience in onco-hematology, and gynecologic oncology clinical trials.

Hace 7 días

Madrid, Area Metropolitana (comarca); Comunidad de Madrid, España Jobrapido Jornada completa
Overview In this CRA II role, you will oversee clinical trial activities to ensure protocol and regulatory compliance across sites. You will work closely with site teams and cross-functional partners to monitor data integrity, patient safety, and trial progress. You’ll apply risk-based monitoring techniques and drive site performance improvements to support study success. This is a mission-driven opportunity to help accelerate healthcare progress through rigorous trial oversight. Compensaciones / Beneficios career development inclusive culture total rewards program peer recognition technical and therapeutic area training supportive line management Responsabilidades Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring ICH-GCP/GPP compliance Assess site performance and provide actionable recommendations; ensure informed consent is properly obtained Verify data quality and source document integrity; perform IP inventory and handling per protocol Ensure accurate IP dispensing, labeling, and release; manage IP labeling/return as needed Review ISF and TMF reconciliation; track observations and action items Coordinate training and communication with site staff; adapt to project scope, budgets, and timelines Provide Real World Late Phase site support, including chart abstraction and collaboration with sponsor affiliates May train junior staff and identify out-of-scope activities for escalation Requisitos principales Bachelor in related field Experience in oncology, hematology, and gynecologic oncology clinical trials Knowledge of GCP/ICH guidelines and regulatory requirements Good computer skills and ability to adapt to new technologies Excellent communication, presentation and interpersonal skills Ability to travel up to 75% strong communication and interpersonal skills adaptability to changing priorities problem-solving and proactive mindset ICH/GCP guidelines GCP/ICH regulatory requirements electronic data capture (EDC) systems usage