We are looking for a CRA based in Portugal to work fully outsourced to our global pharmaceutical client.
Different locations such us Lisbon, Porto and Coimbra are considered.
The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
With full ownership of investigator sites for assigned studies, the CRA´s involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the Clinical Research Associate (CRA) fosters effective relationships with investigator site staff to ensure that key clinical metrics are met.
This involves establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. The Clinical Research Associate may also design and deliver training to site staff, when appropriate.
Typical duties for a Clinical Research Associate will likely include preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues that have occurred at site. The CCRA ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
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