The Clinical Research Associate (CRA) plays a critical role in the delivery of clinical studies at assigned sites. Working closely with local team members, the CRA ensures that study commitments are met in a timely and efficient manner. Key responsibilities include:
\nPerforming identification, selection, initiation, monitoring, site data review and closeout activities/visits, as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
\nDriving performance at the sites by proactively identifying and ensuring timely resolution to study-related issues and escalating them as appropriate.
\nTraining, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.
\nDeveloping recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Documenting recruitment barriers and implementing mitigation plans.
\nEnsuring 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.).
\nPreparing 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.
\nEnsuring 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.
\nIn 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.
\nContributing to the nomination and selection of potential investigators and assisting with feasibility activities.
\nCollaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders, as needed.
\nFollowing 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.
\nPreparing 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.
\nRequired qualifications include:
\nMinimum of 1 year of CRA monitoring experience
\nBachelor's degree in a related discipline, preferably in life science, or equivalent qualification
\nExcellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
\nExcellent knowledge of relevant local regulations
\nGood medical knowledge and ability to learn relevant Alexion Therapeutic Areas
\nGood understanding of the drug development process
\nExcellent understanding of Clinical Study Management, including monitoring, study drug handling, and data management
\nExcellent attention to details
\nExcellent written and verbal communication skills
\nExcellent collaboration and interpersonal skills
\nGood negotiation skills
\nDemonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
\nValid driving license (dependent on country requirements)
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