Company: inVentiv Health Clinical
Closing Date: 07 Dec 16
Salary (£): Negotiable
The position provides country study start-up activities in support of assigned projects. We do offer this role home based across France, ideally close to Paris region.
* 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.
* Previous experience in clinical research or monitoring; 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
* Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
* Occasional travel may be required
* Bachelor's Degree in life science, pharmacy, nursing or RN, Or equivalent clinical research experience
In return we will offer:
* 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 organisation.
* The opportunity to work within a successful and rewarding environment.
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