Sr. Clinical Research Associate (Romania)
Alimentiv, Bucharest
The role
Serving as a primary liaison between investigative sites, Alimentiv and sponsors, the Sr. CRA plays a key role in the successful execution of clinical studies from site selection and start-up through monitoring and close-out. This role also provides guidance and mentorship to CRA I and CRA II colleagues and may participate in CRA assessment visits, co-monitoring activities, audits and inspections.
What you will do
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Independently conduct and document onsite and remote site management activities, including site qualification, initiation, monitoring and close-out visits, in accordance with applicable SOPs and study requirements.
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Serve as a primary point of contact for investigative sites, building effective working relationships and ensuring site questions, issues, action items and protocol deviations are followed through to resolution.
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Review source documentation and study systems to ensure clinical data is accurate, complete and compliant with protocol, regulatory and study requirements; manage and facilitate the resolution of data queries.