PRAHS

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2017-44016

2017-44016

Title 
Clinical Research Associate
Job Locations 
-
United Kingdom
Posted Date 
11/28/2017

More information about this job

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.

 

Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

 

 

Responsibilities

Working within one of PRA’s client-dedicated programs you will be fully-aligned to one Sponsor, performing your role in accordance with their clinical SOP’s, with access to their internal systems and technology platforms. 

 

The Sponsor is a major global pharmaceutical company with a leading portfolio of medicines and vaccines used for Oncology, Neuroscience, Cardiovascular and Infectious Diseases. 

 

Operating within an establised regionalised monitoring model, your key responsibilities are:-

 

  • Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out according to sponsor SOP’s.
  • Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.
  • Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
  • 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.

Qualifications

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 language is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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