Role Description: The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s).
The CRA works in close collaboration with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner.
The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.
They must ensure that the sites deliver according to their respective commitment in the individual studies.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.
Typical Accountabilities: Contributes to the selection of potential investigators.
Accountable for study start-up and regulatory maintenance, including Site Qualification Visits, collection, preparation, review, and tracking of documents for the application process.
Submits proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
Trains, supports, and advises Investigators and site staff on study-related matters, including Risk-Based Quality Management (RbQM) principles.
Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study.
Ensures the sites are inspection-ready at all times.
Actively participates in Local Study Team (LST) meetings and contributes to National Investigator meetings, as applicable.
Initiates, monitors, and closes study sites in compliance with AZ Procedural Documents.
Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
Drives performance at the sites and proactively identifies and ensures timely resolution of study-related issues, escalating them as appropriate.
Updates CTMS and other systems with data from study sites as per required timelines.
Manages study supplies (ISF, etc.
), drug supplies, and drug accountability at study sites.
Prepares study drugs for destruction, if applicable.
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan.
If required, determines and discusses with LSAD the correct timing and type of visits.
Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV), in accordance with the Monitoring Plan.
Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
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