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

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. The position offers exposure to real-world late-phase studies and a collaborative, outcomes-focused culture. 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; escalate serious issues promptly
Maintain knowledge of ICH/GCP, regulations, and SOPs; 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; ensure archiving of essential documents
Support patient recruitment and retention strategies; track observations and action items
Coordinate training and communication with site staff; prepare for meetings and audits
Assist with audit readiness and post-audit follow-up actions; 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