Clinical Research Coordinator

4 weeks ago

Brisbane, Queensland, Australia Pharmiweb Full time
Clinical Trial Assistant Job Description

As a Clinical Trial Assistant, you will be working with the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

Key Responsibilities:

  • Provide administrative support to the Local Trial Manager (LTM)/Trial Manager (TM) and/or Clinical Research Associates (CRAs) for trial feasibility, start-up, execution, and close-out.
  • Ensure trial-related activities comply with SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), and local regulatory requirements.
  • Review regulatory documents, including Informed Consent Forms.
  • Partner with the LTM and CRAs to ensure overall site management while performing trial-related activities for assigned protocols.
  • Collect and prepare documents required for studies, such as start-up/submission to the IEC/IRB and HA, in support of the LTM/TM/SM where applicable.
  • Collect and track financial disclosure information at appropriate timepoints in accordance with procedural documents.
  • Prepare study files for investigational sites and coordinate the development of associated documents and review them for completeness and accuracy.
  • Collect and file all documents throughout the trial and post-trial, using appropriate systems to ensure file completeness at designated study milestones.
  • Coordinate archiving of paper study relevant documents/files.

Requirements:

  • BA/BS degree in Life Sciences, Nursing, or related scientific field (or equivalent experience).
  • 2-3 years of relevant clinical trial assistant experience, with previous experience working on studies in Romania.
  • Proficient in English and Romanian language.
  • Previous experience in preparation and submission of documents to RA/EC.
  • Experience in communicating with sites and local study teams.
  • Experience in eTMF.
  • Strong knowledge of MS Office (Word, Excel, Access, Outlook, Explorer, and PowerPoint).
  • Strong interpersonal and negotiating skills.
  • Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
  • Perform activities in a timely and accurate manner.

What ICON Can Offer:

  • Competitive salary.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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