Senior Clinical Research Associate

3 hours ago


Sydney, New South Wales, Australia GenesisCare Full time
Senior Clinical Research Associate

GenesisCare is seeking a highly skilled and experienced Senior Clinical Research Associate to join our CRO division. 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 project managers with site selection, start-up activities, and contract negotiations.
  • Oversee all aspects of study site management, including data collection, source document verification, and investigational product accountability.
  • 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, contracts negotiation, and HREC submission preparation.
  • Understanding and practical knowledge of ICH-GCP requirements.
  • Willingness to travel to fulfill the requirements of the role.
Benefits:
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Competitive salary and benefits package.
  • Access to internal and external training and development opportunities.
  • Enhanced wellbeing program and range of benefits available.

GenesisCare is a 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. Join us to design better care and enjoy a career with purpose.



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