Site Start Up Specialist
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About The Position
As a Clinical Site Start Up Specialist, you will be responsible for developing awareness of regulatory legislation, guidance, and practices in assigned countries with the support of senior staff. You will assist in compiling, preparing, submitting and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements. Your job will also include liaising with internal and external vendors in the generation of Regulatory Authority submissions. You will perform reviews of final submission documents, organize communication related to the submissions/outcomes within our organization, and escalate study issues appropriately and timely. You will also serve as a primary contact for investigative sites and ensure all necessary documents are collected in a timely manner. The role includes ensuring that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines. You will also be responsible for updating study documents when there are changes in study personnel/study amendments and ensuring high quality documents are filed and systems are updated on an ongoing and timely basis. With guidance from the line manager and experienced colleagues, you'll adapt Informed Consent Forms and other patient facing material to country-specific requirements. The role may also involve supporting/assisting the contract negotiation process under the supervision of an experienced colleague or line manager.
