Company: Docs Global (Continental Europe)
Reference: Ref AS-020254
Closing Date: 23 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Central point of communication between our client and Investigators for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and SOP compliant.
Roles & Responsibilities of the position
• Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial.
• Assume ambassadorial role to facilitate communication between sites and Key Novartis linefunctions to increase value proposition to investigators.
• Facilitate preparation and collection of site level documents.
• Execute site initiation and training activities.
• Perform both on-site and remote monitoring visits according to monitoring plan.
• Manage drug supply at site level.
• Resolve site level update of technical systems (Clin Admin, EDC).
• Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
• Manage recruitment implementing appropriate contingency plans as needed.
• Assure continual CP, ICH and SOP compliance (Informed consent pro-cess, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training.
• Author study monitoring reports.
• Perform data query resolution process (both at Site and with Data Management).
• Execute site closeout activities.
• Act as a full responsible manager of assigned investigational sites.
• Degree in a scientific or health care discipline.
• Fluent English (oral and written).
• Basic medical and business knowledge.
• Desired 3-7 years experience in clinical researchor having demonstrated adequate level of proficiency within the CRA competency profile.
• Understands and can apply knowledge of clinical trial designs to trial execution.
• Knowledge and experience in international Standards (GCP/ICH), international (FDA, EMA) and local regulations.
• Expertise in communication, managing multiple priorities and computer literacy.
Interested? For more information contact me at:
2 Globeside, Globeside Business Park
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