The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at their assigned sites and is an active participant in the local study team(s). The CRA works in close collaboration 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 on a site level. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure delivery and compliance.
The CRA is responsible for the identification, selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations, and that the sites deliver according to their respective commitment in the individual studies.
A CRA with demonstrated skillset and experience may take on additional study level responsibilities and tasks as needed (e.g. Lead CRA, etc).
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).
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. 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.)
Supporting/participating in regular QC checks of the eTMF
In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
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.
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.
~ Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
~ Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
~ Excellent written and verbal communication skills.
~ Solid knowledge of clinical development processes with strong emphasis on monitoring
~ engage in communications via phone, video, and electronic messaging; Ability to work in an environment of remote collaborators and in a matrix reporting structure
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
Experience in all study phases and in rare medical conditions preferred.
The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.