AstraZeneca
Senior Clinical Research Associate
Wilmington, Delaware, United States of America · Senior
Sponsorship not specifiedDetected 1 day ago
GCPProject ManagementNegotiationOperations ManagementClinical TrialsClinical ResearchGMPResearchCommunicationCollaboration
About the role
- CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s).
- CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study.
- CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg.
Responsibilities
- CRA is responsible for the 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.
- Document recruitment barriers and mitigation plans.
- Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements.
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.
- Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to PMCO, Director COM, HCO and/or Quality Group as required.
- Excellent knowledge of relevant local regulations.
Nice to have
- Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- ability to respond quickly to shifting demands and opportunities.
- In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
Benefits
- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
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