Clinical Research Associate

Overview The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at their assigned sites and is an active participant in local study teams. The CRA works closely with local team members (Project Management Clinical Operations (PMCO), Study Start‑Up (SSU) manager, Clinical Study Assistant (CSA), and other CRAs in Clinical Operations Management (COM)) to ensure that study commitments are achieved in a timely and efficient manner at the site level. The CRA acts as the main contact with the study site and is responsible for monitoring study conduct to ensure delivery and compliance. Responsibilities Perform identification, selection, initiation, monitoring, site data review, and closeout activities/visits (remote and onsite), and conduct remote data checks in accordance with the timelines specified in the study‑specific Clinical Monitoring Plan (CMP). Drive performance at sites, proactively identifying and ensuring timely resolution of study‑related issues, escalating as appropriate. Train, support, and advise investigators and site staff on study‑related matters, including Risk‑Based Quality Management (RBQM) principles. Develop recruitment plans with each site and manage and support 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‑item aging, SDV metrics, data‑entry metrics, query aging, MV‑report metrics, etc.). Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to the principal investigator, including follow‑up letters, within required timelines and in line with Alexion SOPs. Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH‑GCP, Alexion SOPs, and local requirements; support/participate in regular QC checks of the eTMF. In some countries, account for study start‑up and regulatory maintenance, including collection, preparation, review, and tracking of documents for the application process; submission of proper applications/documents to EC/IRB and to regulatory authorities for start‑up and throughout the study. Contribute to nomination and selection of potential investigators and assist with feasibility activities. Collaborate with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders as needed. Follow quality issue processes by escalating systematic or serious quality issues, data‑privacy breaches, or ICH‑GCP compliance issues to the global study team, local study team, Country Operations Line Management and/or Quality Group representatives as required. Prepare for and collaborate with activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, Country Operations Line Management, and Quality Group). Qualifications Minimum of 1 year of CRA monitoring experience. Bachelor’s degree in a related discipline, preferably in life sciences, or an equivalent qualification. Excellent knowledge of international guidelines ICH‑GCP and 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. Excellent attention to detail. Excellent written and verbal communication skills. Excellent collaboration and interpersonal skills. Good negotiation skills. Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods). Valid driving license if required. Equal Employment Opportunity Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca