Clinical Research Associate

4 weeks ago


Brisbane, Queensland, Australia Pharmiweb Full time
Job Description

As a Clinical Research Associate at Pharmiweb, you will be working on multiple trials within Oncology, focusing on quality of life and regional travel. Your responsibilities will include:

  • Working on multiple trials within Oncology
  • Quality of life focus with regional travel
  • Demonstrated leadership through involvement in specific initiatives and/or SME to systems and/or processes
  • Mentoring and coaching junior team members
  • Acting as a lead site monitor, training other site monitors on study protocols
  • Developing site start-up documents for studies, including SIV agendas
  • Providing a site monitor's perspective when reviewing study documents
  • Representing local trial managers or site monitors on SMTs and meetings
  • Taking over LTM role reports for sites assigned to other site monitors
  • Supporting country budget development and contract negotiation
  • Assisting with adverse event reporting

Interfaces:

  • Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, and Central Study Team
  • Other interfaces: Study Responsible Physician, Regional Quality and Compliance Manager, Local Drug Safety Officer, and Site Manager team
Requirements

To be successful in this role, you will need:

  • A minimum of a B.S., R.N., or equivalent degree in Biological Sciences
  • Location in Ohio, near a major airport
  • A minimum of 2-3 years' experience in monitoring pharmaceutical industry clinical trials
  • A minimum of 1-3 years' experience monitoring Oncology trials
  • Knowledge of several therapeutic areas
  • Analytical and risk-based monitoring experience is an asset
  • Ability to drive patient recruitment strategies at assigned sites
  • Ability to partner with investigator and site staff to meet study timelines
  • Ability to operate and use various systems and databases
  • Strong communication and influencing skills
  • Knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements
  • Ability to travel up to 50%

At Pharmiweb, we value diversity, inclusion, and belonging. We are committed to providing an inclusive and accessible environment for all candidates. If you need a reasonable accommodation for any part of the application process, please let us know.



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