Job Summary
The Research Compliance Coordinator must be knowledgeable of standard research and oncology care practices. The Research Compliance Coordinator advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care. This Position is based in Barcelona.
Essential Duties and Responsibilities
Essential and other important responsibilities and duties may include but are not limited to the following:
• Protocol Compliance
• Reviews and comprehends the research protocol
• Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research
• Complies with NEXT Oncology SOPs
• Develops and maintains source documents, templates, or forms in a timely fashion.
• Ensure all protocol requirements have been captured on site specific forms, documents, or templates.
• Assesses protocol for discrepancies or questions to ensure accurate source documents and forms are created
• Assess and update forms for protocol amendments or protocol clarification letters
• Assess and update forms when issues are identified during the course of patient treatments
• Participates in quality control activities to ensure data integrity, including timely responses to database or sponsor queries
• Provide monthly reports to team to ensure compliance with protocol specified task
Knowledge, Skills and Abilities
• Bilingual in English/Spanish, preferred
• Knowledge of appropriate software including Microsoft Word, Excel, and Outlook, Microsoft PowerPoint and Adobe Acrobat
• Attention to detail, organizational and accuracy skills
Required Education and Experience
• Oncology clinical trial experience preferred
Send your CV to: ahuerta@nextoncology.eu