Senior Clinical Research Associate

4 weeks ago


Alexandria, Australia GenesisCare Full time
About the Role

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at GenesisCare. As a Senior CRA, you will play a critical role in the management of clinical trials, ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.

Key Responsibilities
  • Monitor clinical trials and ensure compliance with SOPs, regulations, and ICH guidelines.
  • Perform site qualification visits, feasibility assessments, and site initiation visits.
  • Support site management, including contract negotiation and HREC submission preparation.
  • Oversee all aspects of study site management to ensure high-quality data.
  • Maintain eTMF filing and study tracking in Clinical Trial Management System (CTMS).
  • Manage timely site payments and may be delegated with PM-related tasks.
Requirements
  • Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
  • At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical, and/or Biotechnology industry as a SCRA/CRA.
  • Experience in managing early phase oncology trials is highly preferred.
  • Experience in EDC & CTMS.
  • Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
  • Experience in contracts negotiation desirable.
  • Experience in HREC submission preparation.
  • Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.
  • Willingness to travel to fulfill the requirements of the role.
About GenesisCare

By joining GenesisCare, you will be part of a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. We are committed to innovation and working together to drive better life outcomes for patients around the world.

GenesisCare is an Equal Opportunity Employer.



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