Clinical Research Associate

This is a fully remote position, open to applicants in Spain.

📋 Description

• Carry out clinical monitoring tasks at clinical trial sites in line with ICH guidelines, GCP, local regulations, and relevant SOPs.

• Conduct monitoring activities for selection, initiation, execution, recruitment, quality data collection, and prompt completion of oncology/hematology clinical trials.

• Work in collaboration with the Regional Clinical Operations Manager to ensure adherence to study timelines and uphold quality standards.

• Identify deficiencies and opportunities for enhancement, proposing corrective and preventive actions (CAPA).

• Assist with study start-up and offer local expertise.

• Execute feasibility studies, site identification, selection, and evaluation.

• Provide training on the protocol and related study materials to assigned sites.

• Perform pre-study, initiation, routine monitoring, and closeout visits.

• Conduct co-monitoring visits as necessary.

• Complete monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards, and SOPs.

• Oversee site performance by tracking regulatory submissions, recruitment, CRF completion, and resolving data queries.

• Maintain communication with sites and report progress, issues, and recommended actions to Clinical Operations.

• Ensure the study and sites are ready for inspection.

• Collaborate with study sites to achieve study milestones, including startup, recruitment, database analyses, and closeout.

• Participate in disease-indication-specific and general CRA training as required.

• Facilitate Study Oversight Visits, site audits, and/or inspections as necessary.

• Assess site practices and escalate quality and/or GCP concerns.

• Anticipate and identify site challenges, proposing corrective and preventive measures, recognizing gaps, and fostering operational excellence and innovation.

⛳️ Requirements

• Bachelor’s degree in a relevant scientific field and a minimum of 2 years of monitoring experience.

• Experience in global oncology trials is preferred.

• Comprehensive knowledge of ICH and related regulatory guidelines.

• At least 2 years of CRA monitoring experience within the pharmaceutical or CRO sector.

• Experience in oncology/hematology trials is preferred.

• Outstanding communication and interpersonal abilities.

• Strong organizational skills with the capability to prioritize tasks and manage multiple responsibilities.

• Proficient in English and Spanish (both written and spoken).

• Skilled in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness to travel up to 60% of the time.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and training.

• Comprehensive health benefits package.

• Flexible work arrangements.