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Sr/ Clinical Trial Coordinator - Clintec position

Aplica ya
Mapa de ubicación: Athens, Greece Full time R1252410

Descripción del trabajo

Description of Roles and 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
  • Update clinical trial databases (CTMS) and trackers o Clinical supply & non-clinical supply management, in collaboration with other country roles o 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 o Updating manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies. o Prepare Investigator trial file binders
  • 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
  • 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.

Meeting Planning:

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

Experience Required

  • Minimum 1-2 years in Clinical Research or relevant healthcare experience
  • B.A./B.S. (Life Science preferred) or equivalent healthcare experience
  • 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
  • Location: Hibrid model in Athens (3 days in the office)

Behavioural Competency Expectations

  • Effective time management, organizational and interpersonal skills, conflict management
  • Effective communication with external customers (e.g. sites and investigators)
  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
  • Demonstrates commitment to Customer focus.
  • Able to work independently
  • Proactive attitude to solving problems / proposing solutions

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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