Company: Docs Global (Continental Europe)
Reference: Ref AS-017286
Closing Date: 25 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a CRA / Clinical Research Associates with experience in independent on-site monitoring that is ready to further develop their career and enjoy working for a fast growing CRO homebased in Bulgaria area.
Roles & Responsibilities of the position
• Site administration and site monitoring responsibility for clinical studies according to Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines
• Conduction of country and site feasibility
• Performance of initiation, routine monitoring and close-out visits
• Preparation and performance of submissions to Ethics Committee/ Regulatory Authorities
• Assistance in project budget and contract management
• Completing Serious Adverse Event (SAE) reporting, processing, production of report
• University degree in medicine, pharmacy, nursing or biology
• Previous experience in independent monitoring
• Experience in start-up activities, including feasibility activities, preparation and submissions to Ethics Committees/ Regulatory Authorities and contract management is desired.
• Excellent knowledge of English, Bulgarian languages
• Thorough knowledge of ICH-GCP guidelines including an understanding of local regulatory requirements
• Availability to travel
• Strong organizational, communication and teamwork skills
• Computer literacy
• Driving licence
Base Salary, Car Allowance, Medical Insurance, Pension, Life Assurance
For an immediate consideration please send your most recent resume to firstname.lastname@example.org or call Marta on +48 664 490 059.
This is an excellent opportunity that should not be missed, don’t miss out and apply today!
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are: Our People, Excellence, Accountability, and Integrity, Bulgaria, Bulgaria area
CRO, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Permanent, Clinical Research, Associate, Clinical Research Associates, CRA, SCRA, Site Monitor, Site Manager, Therapeutic Areas, Indication, Oncology, Respiratory, Cardiovascular, cardiology, Rheumatology, Diabetes, Ophthalmology, Dermatology, Urology, CNS, Neurology, Top of Form
2 Globeside, Globeside Business Park
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