Career for Clinical Research Associate at PRA Health Sciences

 

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. With our unique blend of expertise, we provide comprehensive clinical development services across all phases. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

Post : Clinical Research Associate

Job Description
Overview
Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

Responsibilities

  • Working fully outsourced to one of our global 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 (CRA) will be involved at site start-up stage; Feasibility and SSV, planning and conducting various site visits (feasibility and site selection) 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.
  • 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.

Candidate Profile
The successful candidate for this role will be able to demonstrate prior experience in feasibility and SSV 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.

Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th August, 2019

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