Country Submission Specialist, Denmark (permanent)
Company: inVentiv Health Clinical
Closing Date: 01 Jan 17
Salary (£): Negotiable
Join Site Centricity Unit within inVentiv Health Clinical in Denmark as a Country Submission Specialist. See and get to know us better - https://youtu.be/YQgaDu0L-CQ.
Role: Country Submission Specialist
Department: Essential Document Collection and Submissions (EDCS), Site Centricity Unit
Contract: permanent, full-time
Location: home-based, Denmark
- 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.
- 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