Clinical Trial Specialist I
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As a Clinical Trial Specialist you will work as a part of our well established team in Moscow. You will be responsible for conduct and facilitate specific start-up activities such as site identification, feasibilities, SRP collection, review and approval, ICF customization and approval, EC and RA submissions, as well as preparation and negotiation of Clinical Site Agreements (CSAs) at a site level with a high accountability on quality and timelines.

Key Accountabilities:
• Action site selection strategy
• Refine project-specific site selection strategy at a country level
• Identify new potential Investigators and enter/update clean information into the tracking systems
• Ensure feasibility, review and approval of site identification list coming from IISS
• Conduct country specific feasibilities and/or site pre-qualification and/or remote qualification visits and/or site selection activities
• Create country specific / site specific (if necessary) Informed Consent Form (ICF)
• Review and approve country specific ICFs (if necessary)
• Prepare and negotiate clinical site agreement at a site level
• Prepare and submit IRB/EC application until final approval received
• Customize SRP Guidelines
• Collect and compile regulatory documents in collaborations with the CRA and CMA
• Review and approve SRP
• Immediately update tracking system once regulatory documents are approved
• Adapt drug label for country requirements in cooperation with Regulatory and the Logistics Team (if applicable)
• Organize translations per country/regulatory/client requirements
• Submit safety updates to IRB/IEC (if applicable)
• Prepare and submit MOH/RA documentation and follow-up until final approval received (Initial submission/Amendments), where applicable in countries fulfilling responsibilities of regulatory services
• Assist with QC/audit of central files and liaise with Quality Assurance personnel as required.

Qualifications:
• Degree in a life science, nursing qualification or other relevant experience preferred
• Strong computer and internet skills including knowledge of MS-Office products such as Excel and Word
• Strong regulatory knowledge including GCP and local laws
• Excellent interpersonal, verbal and written communication skills
• Sound problem solving skills
• Ability to successfully work in a ‘virtual’ team environment
• Client focused approach to work with the ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Able to take initiative and work independently
• Sense of urgency in completing assigned tasks
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work
• Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel)
• Competent in written and oral English in addition to local language
 
Additional Information
Location | | | Moscow Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013


Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided
 

       

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