We are looking for a CRA based in the North of Portugal to work fully outsourced to our global pharmaceutical client.
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.
The successful candidate for this role will be able to demonstrate prior experience as a CRA of 2-3 years working in international clinical trials, from either a pharmaceutical company or a CRO environment.
Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Fluency in English and Portuguese is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
As a PRA employee you will work for one of the Top 5 CROs over the world. We offer interesting social benefits plus a salary according to the experience.
At PRA we offer flexible working hours to keep a good work-life balance.
Growth opportunities are also available for PRA employees.
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