Senior Clinical Research Associate

3 weeks ago


Newcastle, New South Wales, Australia Pharmiweb Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team. As a key member of our clinical research organization, you will be responsible for managing clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.

Key Responsibilities
  • Manage multiple clinical trials within the Oncology therapeutic area
  • Develop and implement quality control processes to ensure data accuracy and integrity
  • Collaborate with investigators, site staff, and other stakeholders to ensure successful trial execution
  • Provide training and support to junior team members
  • Develop and maintain site start-up documents, including SIV agendas
  • Review and provide feedback on study documents, such as Monitoring Guidelines
  • Represent the team at SMTs and meetings
  • Take over LTM role reports review for sites assigned to other SMs from the same trial
  • Support country budget development and contract negotiation
  • Assist with ASV and metrics/KPIs
Requirements
  • Based in the Los Angeles, CA area (near a major airport)
  • Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
  • Minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials
  • Minimum of 1-3 years' experience monitoring Oncology trials
  • Knowledge of several therapeutic areas, with Oncology an asset but not a requirement
  • Analytical/risk-based monitoring experience is an asset
  • Ability to actively drive patient recruitment strategies at assigned sites
  • Ability to partner closely with investigator and site staff to meet all of our study timelines
  • Ability to operate and use various systems and databases
  • Strong communication and influencing skills
  • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements
  • Need to travel up to 50%
What We Offer
  • Competitive salary range ($98,312 USD - $122,890 USD)
  • Annual leave entitlements
  • Range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme
  • Life assurance
  • Flexible country-specific optional benefits

We are an equal opportunities employer and welcome applications from diverse candidates. If you require reasonable accommodations during the application process, please let us know.



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