Site Activation Partner

Employer
PRA Health Sciences
Location
Poland
Salary
Competitive
Closing date
10 Oct 2020

View more

Discipline
Clinical Research, Clinical Operations, Operations, Site services
Hours
Full Time
Contract Type
Permanent
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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 Site Activation Partner, you are responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and standards. 

The main responsibilities are:

  • Assist with study site activation activities to ensure timely site activation
  • Support and/or coordinate the whole regulatory submission process in collaboration with the investigator sites (confidentiality agreements, study contracts, clinical supply shipment information, payment information, etc.)
  • Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
  • Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
  • Support investigator sites and clinical operations team in preparation for and providing responses to site audits/inspections
  • Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation
  • Provide support with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and standards
  • In collaboration with other team members oversee site budget and contract negotiations, facilitate site payments, conduct remote monitoring activities
  • Provide other technical or logistical supportive activities that facilitate inspection readiness
  • In collaboration with other team members identify and resolve and investigator site issues within required time frames

You are:

Organised, creative and confident in taking independent action.

To ensure success within this role, the following are required:

  • Undergraduate degree or its international equivalent in clinical, science, or health related field
  • Minimum of 2 years of experience in clinical site management
  • Experience with PC-Windows, word processing, and electronic spreadsheets required
  • Knowledge of ICH and local regulatory authority drug research and development regulations required
  • Clinical trials support or pharmaceutical industry experience required
  • Fluent in English and Polish with effective verbal and written communication skills
  • Proven ability to work independently and also as a team member
  • Ability to organize tasks, time and priorities

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

The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs.

More than anything else, our story would be about people. Not only our over 16,000 + employees operating in more than 80 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.

Contact Us
  • 500 South Oak Way
  • Green Park
  • Reading
  • RG2 6AD
  • GB
  • +44 (118) 918 1000
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