A leading global CRO, PRA is transforming clinical trials through our people, innovation and transparency. We serve clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge PRA’s commitment to excellent in research begins with our people. Our workforce has grown by over 25% since 2010 and now comprises over 4,700 employees spanning more than 13 time zones and speaking more than 15 languages. It is our philosophy that the way in which we grow our business is to focus on our employees and as such, we recognize that successful careers are found within organisations that provide the support that employees need at work, as well as the benefits they require outside the office.
Post : Clinical Research Associate
Responsibilities
1) 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.
2) 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.
3) 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.
4) The Clinical Research Associate may also design and deliver training to site staff, when appropriate.
5) 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 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.
Additional Information
Job ID : 2018-45872
Location : India
Industry Type : Clinical research
Functional Area : CRA
End Date : 20th May, 2018
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