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In-house CRA, Russia - FSP Moscow

Moscow
2021-05-19 00:40:42
In-house CRA, Russia - FSP Moscow
Job Overview
Covance is looking to recruit an in-house CRA to join our sponsor in Moscow Responsibilities : - Trial and site administration: - Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) - Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers - Clinical supply & non-clinical supply management, in collaboration with other country roles - Manage Labeling requirements and coordinate/sign translation change request - Document management: - Prepare documents and correspondence - Collate, distribute/ship, and archive clinical documents o Assist with eTMF reconciliation - Updating manuals/documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies. - Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents - Regulatory & Site Start-Up responsibilities: - Provide to and collect from investigators forms/lists for... site evaluation/validation, site start-up and submissions - Obtain, track and update study insurance certificates - Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. - Publish study results for GCTO and RA where required per local legislation - Budgeting, Agreement and Payments: - Collaborate with finance/budgeting representatives for: - Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations - Maintenance of tracking tools - Contract development, negotiation, approval and maintenance (e.g. CTRAs) - Update and maintain contract templates (in cooperation with Legal Department) - Payment calculation and execution (investigators, vendors, grants) - Ensure compliance with financial procedures - Monitor and track adherence and disclosures, - Budget closeout.
Education/Qualifications
- University Degree
Experience
- Minimum 1-2 years in Clinical Research or relevant healthcare experience - Fluent English and local language
Moscow Russia
In-house CRA, Russia - FSP Moscow Covance Moscow
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Afla pretul site-ului tau! Bucuresti IA RO
Afla pretul site-ului tau!
Bucuresti IA RO

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