Overview In this CRA role, you will lead clinical monitoring at trial sites to ensure quality data and adherence to ICH-GCP and local regulations. You will collaborate with regional operations to meet study milestones and identify gaps for CAPA. The position supports site start-up, training, and ongoing oversight in oncology/hematology trials.

You will work in a cross-functional team to uphold regulatory standards and study integrity, contributing to faster, safer cancer research. This role offers meaningful impact by ensuring site readiness and timely trial execution in a fast-paced environment.

Responsabilidades

Feasibility, site identification and evaluation to support site list and recruitment targets

Provide protocol and study training to sites

Conduct monitoring visits (pre-study, initiation, routine, closeout) per plan and SOPs

Co-monitoring visits when required

Complete monitoring visit reports per ICH-GCP and internal standards

Manage site performance by tracking regulatory submissions, recruitment, CRF completion, data query resolution





Establish regular communication with sites and report progress/issues to Clinical Operations

Ensure inspection readiness of studies and sites

Collaborate with Regional Clinical Operations Manager to meet milestones (startup, recruitment, database analyses, closeout)

Attend disease indication-specific and general CRA training

Facilitate Study Oversight Visits, site audits, and inspections as required

Evaluate site practices for quality and integrity; escalate issues and propose CAPA

Identify gaps and opportunities; promote operating excellence and innovation

Requisitos principales Clinical trial monitoring experience in oncology/hematology (CSA context)

Ability to travel

Experience with regulatory submissions and data quality processes

Strong communication with sites and internal teams

Experience with CAPA and quality improvement processes

Knowledge of ICH-GCP and SOPs

SSU experience is a plus

Collaborative

Proactive problem-solving

Attention to detail

MS Word

MS Excel

MS Project

📌 Clinical Research Associate (Santiago de Compostela)
🏢 Beigene
📍 Santiago de Compostela