Company: Docs Global (Continental Europe)
Reference: Ref AS-018391
Closing Date: 10 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
If you are an experienced clinical professional looking for an opportunity with a rapidly growing and fast paced global leader on an interesting and complex project this would be a compelling role for you.
Roles & Responsibilities of the position
Responsible for the support and management of study sites for Phase II- IV clinical studies according to SOP’s, GCP regulations and protocol requirements.
Identify, evaluate and recommend potential study sites for participation based on feasibility
Perform pre-trial assessment visits and coordinate site initiation visits
Assures that site personnel complete and document protocol-specific training
Conducts on-going study visits and perform Monitoring visits on a routine basis
Performs source documentation as required by SOP to ensure protocol/patient compliance
Reports any site issues to Clinical Team
Ensures that Trial Centre File (TCF) is current up to date
Performs drug accountability and any re-labelling that may be required
Responds to site questions and escalates as necessary for resolution
Attends investigator meetings
Participate in QA or FDA audits when necessary
Education: BSN/BS/MS or BA required
Experience: a minimum of two years Clinical Research experience
Knowledge of Microsoft Office applications especially Excel
English: Fluent spoken & written
Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker
Ability to collaborate and build strong relationships with all functions involved in the trial
Works and meets deadlines with some supervision
This is a permanent role through DOCS contracted to our client on a no end date basis.
Full time, permanent and home based in several locations in Italy.
2 Globeside, Globeside Business Park
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