Within this position you will be mainly focusing on local ethic and competent authority submissions, joining an already established local team in the UK.
* 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.
* Complete necessary administrative tasks.
* May perform other duties as assigned.
* Train and mentor other associates on local regulations and internal procedures.
* Complete assigned training programs and apply learning.
* Undergraduate degree or RN in a related field or equivalent combination of education, training and experience
* Solid clinical research/monitoring experience including 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
* Occasional travel may be required
* A competitive remuneration package with excellent benefits.
* A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
* The opportunity to work within a successful and rewarding environment.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV or contact Mareike Schönberg on +49 6102 813 227.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health Clinical delivers high quality drug development programs and clinical staffing solutions of all sizes around the world to achieve our vison - Shortening the distance from lab to lifeTM