PRAHS

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2017-43105

2017-43105

Title 
Site Activation Manager / Site Contracting Representative/CRA
Job Locations 
-
Italy
Posted Date 
10/18/2017

More information about this job

Overview

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 45+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. 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.

 

At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

Responsibilities

We are looking for a Site Start Up CRA based in Italy to work sponsor dedicated, both in the Start up and monitoring activities. 

 

One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. Enter: the Strategic Solutions Division.

 

Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.

 

As a Senior SSU Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

 

Position overview:

 

Working directly with investigative sites across the country, the Senior SSU Clinical Research Associate  plays a fundamental role in our client’s drug development process. The main focus will be working independently to manage the study start-up activities at a country level, negotiate contracts and conduct site management and monitoring throughout the project lifecycle.

 

This is a unique position, combining different aspects of clinical drug development including study start up, site contracts and on-site monitoring.

 

Key tasks will include:

 

  • Working directly with investigative sites for all aspects of start start-up, including site activation strategy and timeline development, regulatory document collection and preparation, IRB / EC submissions and informed consent review
  • Managing submissions including the coordination of submissions packages, responding to EC queries
  • Creating and customising patient informed consent forms
  • Negotiate site specific budgets and contracts, project managing and tracking the site contract and budget tracking process
  • Monitor the progress of the clinical study at site, ensuring compliance to SOPs, ICH-GCP and the study protocol, carrying out training of site staff, assessing IP accountability and verifying the report of serious adverse events
  • Providing study updates to the wider project team
  • Identify any areas of risk and implement relevant mitigation plans

 

Interfacing with other key stakeholders in the business including the medical team and project management, the Senior SSU Clinical Research Associate´s expertise will be called upon to work independently, taking ownership for study progress and acting as a key contributor to the project team.

 

 

Qualifications

 

You are:

 

Organised, confident and quick to learn.

 

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • A proven track record of success in study start-up activities in either a CRO or pharmaceutical company, including submissions, managing timelines and driving delivery
  • A thorough understanding of the budgeting and contracting process for investigative sites
  • Previous experience in on-site monitoring
  • Strong organisational skills, the ability to work well under pressure and collaborate with others
  • Fluency in English

 

The ability to communicate confidently and learn quickly are also key attributes in this unique position.

 

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

 

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

 

For more information please visit our website: www.prahs.com

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