[Alexion] Clinical Research Associate

About the Company

Responsibilities

• ● 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 escalates 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.
• ● Ensure 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 provide timely feed-back to the Principal Investigator, including follow-up letter, 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, representativesas 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.
• ● You will need to have:
• ● Minimum of 1 year of CRA monitoring experience
• ● Bachelor's degree in related discipline, preferably in life science, or equivalent qualification
• ● Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• ● Excellent knowledge of relevant local regulations.
• ● Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
• ● Good understanding of the drug development process.
• ● Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.