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Vacancy details
Vacancy description:
Job Code:
2275pv
Job Title:
Clinical Research Associate (m/f)
Job Category:
Clinical Research
Contract:
Locum/Temporary
Discipline:
CRA
Country:
Germany
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
06 Jun 2008
Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience of running and staffing international Phase I to Phase IV clinical trials across a broad therapeutic range for a wide variety of clients. Chiltern employs more than 1200 people with 20 offices across the United States, Europe and in India. Chiltern provides services including Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions.
For one of our clients, a pharmaceutical company based in Vienna, we are searching two experienced
CRA´s (m/f)
to work office-based, in a fulltime position for a duration of 1-2 years.
Responsibilities:
Assist with site selection by conducting investigator/site phone interviews and completing feasibility questionnaires
Conduct study site monitoring visits (qualification, initiation, interim, and closeout) to manage overall compliance to the protocol, Monitoring Plan, FDA Regulations and ICH/GCP Guidelines, applicable SOPs and other applicable regulatory regulations
Prepare study site visit monitoring reports and site visit letters in a timely manner and in accordance with the Monitoring Plan and applicable SOPs
Collect and review essential documents from study sites for accuracy and completion including site informed consents.
Assist with the development of various forms/templates including the informed consent/assent template, study site budgets, CRFs, and any other study specific forms.
Negotiate site budgets
Primary contact for CRAs and study sites to answer protocol questions
Review other study documents such as protocols, Investigator’s brochures, and monitoring plans.
Collect and report adverse experiences per SOP and protocol requirements
Able to assist Clinical Project Coordinator and provide direction when needed on various tasks including site payments, newsletters, timelines, and SAE reporting
Assist with database lock by participating in data listing review
Assist with vendor set-up and vendor management
Communicate with various vendors and CRO staff to ensure timely follow-up.
Handling/coordinating study product shipments
Communicates all relevant and critical issues to management
Participate In and present at Investigator meetings
Participate on SOP committees
Participate in regular meetings
Other duties as required
Requirements:
Has familiarity with US Federal Food and Drug Administration, ICH/GCP, and European Regulatory Authority requirements as applicable to a study.
Has ability to read and interpret medical charts and understands the disease under study and the aim of the therapy. Should be able to understand all sections of the protocol.
Demonstrates proficiency in computer operations in Windows environment and is able to utilize available software for documents, spreadsheets and electronic mail.
Must be able to handle multiple projects at a time and have strong attention to detail.
Excellent verbal and written communication skills in German and Englisch required. Able to produce accurate and well-presented documents including site visit monitoring reports.
Interpersonal and organization skills are a must. Be able to effectively listen and ask questions for clarification. Be able to provides positive direction to team and identifies problems in order to works towards a solution.
Must be flexible in order to accommodate changes in team and project needs. Ability to travel 50% to 75% of the time.
This position is primarily sedentary work with the incumbent working in usual office working conditions with occasional walking/standing with a maximum of 30 lb. Regular attendance is required.
1-2 year experience in clinical research.
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