.Location: Barcelona onsite 3 days at the office and 2 days at home.The Clinical Research Associate (CRA) is responsible for managing clinical studies at assigned sites and serves as the primary contact with study sites.
Working closely with the local study team, the CRA ensures timely and efficient delivery of study commitments, overseeing site identification, selection, initiation, monitoring, and closure.
The CRA ensures compliance with Alexion procedures, ICH-GCP guidelines, and local regulations, ensuring sites meet their commitments in each study.You will be responsible for: Performing identification, selection, initiation, monitoring, site data review and closeout activities/visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
Driving performance at the sites.
Proactively identifying and ensuring timely resolution to study-related issues and escalating them as appropriate.
Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.
Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones.
Document recruitment barriers and implement mitigation plans.
Ensuring agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator, including follow-up letters, within required timelines and in line with Alexion SOPs.
Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements.
Supporting/participating in regular QC checks of the eTMF.
In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance.
Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.
Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed.
Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to Global Study team, Local study team, Country Operations Line Management and/or Quality Group representatives as required.
Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.G., PMCO, Country Operations Line Management, and Quality Group)