Company: Docs Global (Continental Europe)
Location: Tel Aviv area,Israel
Reference: Ref AS-019125
Closing Date: 23 Feb 17
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 global organisation in their offices in Tel Aviv area. .
Roles & Responsibilities of the position
As a Clinical Research Associate you will be involved in clinical trial co-ordination and investigational site management. You will serve as primary contact point between the sponsor and the investigational site.
• Responsible for ensuring compliance with the protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out
• Site selection, site initiation, monitoring and close-out.
• Acts as primary local company contact for assigned sites for specific trials.
• Ensures site study supplies are adequate for trial conduct.
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management
• Fully documents trial related activities in particular monitoring, writes visit reports and uploads into systems.
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Ensures site staff completes the data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs and SAEs are reported within the required reporting timelines and documented as appropriate.
• Promptly communicates relevant status information and issues to appropriate stakeholders.
• Prepares trial sites for close out, conduct final close out visit.
• Negotiates investigator budgets at site level and tracks costs at site level and ensure payments are made, if applicable.
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
• Life science degree is required.
• Previous experience of on-site clinical trial monitoring experience is preferred.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Proficient in speaking and writing the country language and English.
• This is a full time office-based role - you need to be available to work 42.5 hours per week. (8-17:00)
Base salary, 13th salary, medical insurance, company car, 21-30 days annual holiday and other benefits.
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: email@example.com
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.
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2 Globeside, Globeside Business Park
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