Clinical Research Associate – SMM (12 month FTC/Secondment)
x2 Positions
Location: Field-based
Salary: Competitive with excellent employee benefits!
The Clinical Research Associate (CRA) has local responsibility for the delivery of the 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 and 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.
CRAs might have different internal titles based on the experience level (CRA, Senior CRA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head).
Typical Accountabilities
Contributes to the selection of potential investigators.
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In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
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Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
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Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
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Actively participates in Local Study Team (LST) meetings.
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Contributes to National Investigators meetings, as applicable.
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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.
Essential Requirements
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Bachelor degree in related field, preferably in life science, or equivalent qualification (*).
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Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
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Good knowledge of relevant local regulations.
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Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
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Basic understanding of the drug development process.
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Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
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Excellent attention to details.
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Good written and verbal communication skills.
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Good collaboration and interpersonal skills.
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Good negotiation skills.
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Ability to travel nationally/internationally as required.