PRAHS 2016-37273 in United States
At PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug discovery forward, helping them to develop life-saving and life-improving drugs. PRA has more than 10,000 employees working in 80+ countries providing comprehensive clinical development services across all phases.
From full service clinical development to the pioneering Embedded Solutions™ model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 50+ such drugs.
Working fully outsourced to and based at the offices of 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 Clinical Research Associate’s (CRA) 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 Clinical Research Associate (CRA) ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
Operating as a key part of a global study team, the CRA plays a fundamental role in our client’s drug development process.
The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, 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 is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.