Company: inVentiv Health Clinical
Location: South Africa
Closing Date: 10 Nov 16
Salary (£): Negotiable
inVentiv Health are currently recruiting for a Freelance Country Submission Specialist II, South Africa (6 month contract). This role will provide country study start-up activities for 1 particular study and will be responsible for EC and CA submissions and review / collection of essential document from sites. We are looking for someone who is able to commit to us on a 0.5 FTE basis for a 6 month period and is able to start immediately. ...
inVentiv Health are currently recruiting for a Freelance Country Submission Specialist II, South Africa (6 month contract). This role will provide country study start-up activities for 1 particular study and will be responsible for EC and CA submissions and review / collection of essential document from sites. We are looking for someone who is able to commit to us on a 0.5 FTE basis for a 6 month period and is able to start immediately.
• Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal.
• Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
• Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
• Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
• Complete review of essential documents following Essential Document Checklist QC.
• Arrange and review translations of relevant study documents.
• Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
• Support other departments as necessary
• Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
• Train and mentor other associates on local regulations and internal procedures.
• Complete assigned training programs and apply learning.
• Complete necessary administrative tasks.
• May perform other duties as assigned.
We are looking for the following:
• Undergraduate degree or RN in a related field or equivalent combination of education, training and experience
• Two and one-half (2.5) years clinical research/monitoring experience including two (2) years study start-up experience
• Ability to learn and follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work with minimal supervision in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate good computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Occasional travel may be required
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