CRA II​/III

We are a Barcelona-based fastest-growing company founded by scientific experts . We are dedicated to the  design and management of innovative strategic clinical trials in oncology,  from study conception to the publication of study results . Together, we create the best strategies that are both clinically relevant and scientifically meaningful . We strive to improve our knowledge of this complex disease and the vast array of available treatments in a fast-innovative way .
At MEDSIR, you will have the job of your life while working together towards our shared mission bringing novel treatments to cancer patients worldwide. We welcome top performers that will bring new ideas, diverse perspectives, and provide you the opportunities and freedom to grow and make a real impact in patients' lives and science… all while having great fun .
ABOUT THE OPPORTUNITY  As a  Clinical Research Associate (CRA) II/III , you will play a key role in ensuring the successful execution of oncology clinical trials. You will  combine on-site monitoring activities (if needed) with leadership responsibilities , acting as a liaison between sites, CRAs and cross-functional teams.
HOW YOU WILL CONTRIBUTE    Site Monitoring Support & Training :
Conduct pre-study, initiation, routine monitoring, and close-out visits to ensure protocol compliance, ICH-GCP, and regulatory requirements. Provide guidance and training to site staff on recruitment strategies, protocol updates, and data entry practices.
Patient Safety & Data Integrity :
Oversee patient recruitment and enrolment processes, review source documentation, CRFs/eCRFs, and resolve data discrepancies in collaboration with site staff and cross-functional teams.
Investigational Medicinal Product (IMP) Oversight :
Manage IMP logistics end-to-end, including forecasting, shipment coordination, and accountability. Ensure proper handling, storage, and chain-of-custody compliance, and address discrepancies identified by CRAs or site personnel.
Vendor & Sample Management :
Coordinate patient sample collection, shipment, and tracking with central laboratories and vendors. Ensure documentation accuracy and resolve operational challenges promptly.
Query Resolution & Documentation :
Collaborate with site staff to reconcile discrepancies, maintain audit-ready documentation, and adhere to established timelines for query closure. Consolidate updates from CRAs, central labs, and vendor portals to maintain a real-time overview of outstanding items. Work closely with Medical Monitors (MM) and cross-functional teams to prioritize and resolve queries, ensuring minimal impact on study timelines and patient safety.
Stakeholder Engagement & Communication:  Act as the principal liaison with investigators, site coordinators, CRAs, Medical Monitors, and other stakeholders. Facilitate clear communication and timely updates on recruitment, site performance, and study progress.
Protocol & Regulatory Compliance:  Confirm site compliance with ICH-GCP, local regulations and protocol-specific requirements. Identify and document protocol deviations or violations, collaborating with site teams on corrective and preventive actions.
Risk & Quality Management :
Proactively identify risks and protocol deviations, perform root-cause analysis, and collaborate with QA and Project Managers on corrective and preventive actions (CAPAs). Ensure inspection readiness through comprehensive documentation in the Trial Master File (TMF) and Investigator Site File (ISF).
Trial Communication :
Lead the preparation of study newsletters, investigator updates, and other communication materials to ensure sites remain informed of safety alerts, milestones and protocol amendments.
Documentation & Reporting:  Maintain up-to-date the essential documents in the trial master file (TMF) and Investigator Site File (ISF).
Support inspection readiness  by ensuring traceability of all site-level actions and a thorough record of trial activities, if needed.
WHAT DO WE VALUE FOR THIS OPPORTUNITY    Bachelor’s degree in Life Sciences, Clinical Research, Nursing, Pharmacy, or a related field.
At least 2 years of experience in site monitoring or clinical…