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Clinical Research Coordinator

aplique agora
Localizações: Bucareste, București Full time R1282455

Job description

Essential Functions

Trial and site administration:

  • Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • 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 o Collate, distribute/ship, and archive clinical documents
  • Assist with eTMF reconciliation
  • Updating manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies. o Prepare Investigator trial file binders o Execute eTMF Quality Control Plan
  • Obtain translations of documents

Regulatory & Site Start-Up responsibilities:

  • In a timely manner, 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 o 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) o Ensure compliance with financial procedures
  • Monitor and track adherence and disclosures,
  • Budget closeout.

Meeting Planning:

  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

Requirements:

  • Minimum 1-2 years in Clinical Research or relevant healthcare experience
  • B.A./B.S. (Life Science preferred) or equivalent healthcare experience
  • Strong experience implicated in FCPA process and payments.
  • Experience in regulatory field in an advantage.
  • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
  • .Hands on knowledge of Good Documentation Practices
  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
  • ICH-GCP Knowledge appropriate to role

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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