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Job Details

Site Start Up Associate - Sofia, Bulgaria (Contract)

Company: Premier Research
Location: Sofia, Bulgaria - home or office based
Reference: 606CC
Closing Date: 19 Jul 17
Type: Contract
Salary (£): Competitive
Benefits: N/A

Job Summary:

Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a freelance Site Start Up Associate in Bulgaria to join our team! This position is offered as a 0.5 FTE for a contract period of 6 months.

Requirements:

We’re looking for a talented and energetic Site Start Up Associate to join our team in Sofia, Bulgaria! This is a part-time (0.5 FTE) contractor position and can be offered as either a home or office based role.

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of seniority or location. 

Premier Research is going through exciting times and there is a true buzz throughout the company - come and be part of it!!

In the role of Site Start Up Associate, you'll be accountable for:

Quality deliverables at the country level for site start-up in one or more components
Forecasting submission/approval timelines and ensuring they are adhered to.
Essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
Progressing and tracking site recruitment and approvals according to study timelines
Ensuring accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF
Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies.
Setting up and maintaining a country folder with country Ethics Committees and local authority addresses and requirements
Documenting QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client

You'll need this to be considered:

BSc, MSc or equivalent
Prior experience in Clinical Research with experience in start-up activities
Prior experience using computerized information systems preferred
Ability to read, write, and speak fluent English and Bulgarian
Clinical trials support or pharmaceutical industry experience preferred
Knowledge of ICH and local regulatory authority drug research and development regulations preferred

 

Apply for this job: Site Start Up Associate - Sofia, Bulgaria (Contract)

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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