Senior Clinical Research Associate /Associate Project Manager

About the role:
Are you looking for a new and amazing opportunity to join an innovative biotech company to develop your clinical research career and make a positive and impactful difference to the lives of others through Clinical Research? Join Amplificare Pty Ltd!

As a Senior Clinical Research Associate /Associate Project Manager you will be working on our novel radiopharmaceutical pipeline and become part of an experienced and dedicated team that promotes personal development and supports a healthy work life balance.

Your responsibilities include performing all duties of a Monitor to ICH -GCP standards and coordinating with cross-functional project teams and external CROs/vendors to ensure quality execution of all Amplificare clinical studies on time, and within budget.

 
To thrive in this role, you’ll need

  • Experience in clinical monitoring and site management
  • Good understanding of ICH-GCP, and relevant local regulations
  • Sound knowledge of the drug development process
  • Outstanding communication, organisational, and problem-solving skills
  • Demonstrated ability to deliver results to the appropriate quality and metrics
  • To be a self-starter, capable of working with minimal direction and seeking a role that fosters personal growth

 Key Responsibilities

  • Performing all duties of a Monitor to ICH -GCP standards including sites selection, initiation, monitoring, site management, TMF management, and site close -out.
  • Coordinating with cross-functional project teams and external CROs/vendors to ensure quality execution of all Amplificare clinical studies on time, and within budget.
  • Administering protocol and study training at assigned sites, fostering ongoing communication and issue resolution.
  • Managing site recruitment efforts, and adjusting the strategy to meet targets if required.
  • Ensuring the quality of study site practices, escalating quality issues when necessary
  • Supporting study startup activities including HREC and regulatory submissions

 Qualifications

  • A Bachelor’s degree in Life Sciences or a related field
  • A minimum of three years of clinical monitoring experience
  • The ability to establish effective working relationships with a diverse range of stakeholders
  • Proficiency in applying ICH_GCP guidelines and regulatory requirements

 How to Apply

If you’re enthusiastic about this opportunity and possess the qualifications we’re seeking, we’d love to hear from you. Please submit your resume and a cover letter to : Jo@amplificare.com.au.

Please only apply if you are a Sydney-based candidate with the right to work in Australia!