Senior Clinical Trials Specialist

5 days ago

Adelaide, South Australia beBeeClinicalResearchAssociate Full time $80,000 - $115,000
Job Opportunity: Clinical Research Associate

We are seeking a skilled and experienced Clinical Research Associate to join our team. The successful candidate will be responsible for ensuring the rights and well-being of trial participants are protected, and reported trial data is accurate, complete, and verifiable from source documents.

This role involves building strong relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient, timely, and productive project delivery as per study requirements and timelines.

Key Responsibilities:
  • Build and maintain strong relationships with Investigational Sites, Novotech and Sponsor teams.
  • Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
  • Collaborate with In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submission and approval processes.
  • Understand and implement local and international regulatory requirements as relevant to specific clinical trials in collaboration with Regulatory Start-up (RSU) Team.
  • Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
  • Monitor investigational sites as per ICH GCP guidelines, including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits.
Requirements:
  • Graduate in a clinical or life sciences-related field.
  • Relevant experience/qualifications in allied professions may also be considered.
  • Good time management skills, attention to detail, ability to work well in a team, and computer literacy.
  • Experience working in the research, pharmaceutical industry or a related field, with specific requirements varying by job level.
  • Full unrestricted working rights in Australia are required.

A competitive compensation package and opportunities for professional growth and development await the successful candidate.

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