in-house CRA, Czech Rep - FSP Job Listing at Covance by Labcorp in Prague (Job ID 10024_58872)

Description

Job Overview:

Covance is looking to recruit in-house CRA (Clinical Trial Coordinator) to join our sponsor in Czech Rep

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.

• University Degree

• Proven experience in Clinical Research or relevant healthcare experience
• Fluent English and local language