Company: Docs Global (Continental Europe)
Reference: Ref AS-020056
Closing Date: 24 Jan 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 Bucharest 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.
• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits.
• Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
• Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
• Critically reviews and analyses site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. • Ensures quality of data submitted from study sites and assures timely submission of data.
• Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines.
• Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
• Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
• Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
• Appropriately escalates serious or outstanding issues to line manager and project team members.
• Facilitates the Regulatory Compliance audit process, as needed.
• Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as mentor to other colleagues as assigned.
• Minimum of a Bachelor of Science degree in a health related field
• Ability to work office-based
• 1.5 - 2 year of independent on-site monitoring experience with multi therapeutic area experience – particularly strong oncology
• Experience in risk-based monitoring would be an advantage
• Previous large pharmaceutical experience preferred.
• Demonstrated success in working independently
• Strong communication and leadership skills
Base salary, medical insurance, car allowance, 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: firstname.lastname@example.org
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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