In-house CRA, Russia - FSP

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