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Study Start Up Associate (SSU)

Job Title: Study Start Up Associate (SSU)
Contract Type: Permanent
Location: West Ryde, Australia
Industry:
Salary: $75000 - $100000 per annum
Start Date: 2018-08-12
Reference: BH-87887
Contact Name: Dean Coleman
Contact Email: dean.coleman@nesgt.com
Job Published: August 14, 2018 00:08

Job Description

Study Start Up Associate

Main Responsibilities:


  • Manage the site activation processes
  • Communicate with investigators locally to assess feasibility
  • Ethics and TGA submissions
  • Conduct Pre- Study- Visits to provide information leading to decisions for site qualification
  • Liaise with internal departments to ensure submission activity is aligned with start- up activities
  • Be accountable for preparing country and site level ICF and amendments in compliance with rules and regulations
  • Sourcing, managing, inventory and delivery of IP and non-IP supplies and its destruction as applicable.
  • Initiate and maintain country study budget activities/negotiations and prepare site budgets
  • Review clinical trial survey results and contribute to the development and implementation of action plans
  • Be accountable for the preparation of investigator Trial Master File (iTMF)
  • Prepare and maintain country TMF and ensure it is inspection ready at all times
  • Drive site activation of clinical study sites


Experience:

  • 1-2 years Experience as a CTA, CTC or Study Coordinator from similar global pharmaceutical/biotech/CRO/Research Institutions
  • OR experience as a CRA in the start up team looking to move away from travel. 
  • Ability to execute within a fast-paced environment
  • Strong interpersonal skills, including relationship building and networking
  • Strong negotiation skills
  • ICH Good Clinical Practice knowledge
  • Previous health-related, scientific field or equivalent work experience
  • Demonstrated proficiency of computer skills (ex. Excel, Word, PowerPoint, IMPACT)

If you are interested in this role, please send a copy of your resume to dean.coleman @ nesgt.com or call for a confidential discussion on 02 9696 8016