Clinical Research Lead

2 weeks ago

Sydney, New South Wales, Australia beBeeResearch Full time $90,000 - $130,000
Senior Clinical Research Associate

We are seeking a skilled Senior Clinical Research Associate to join our team. In this role, you will be responsible for overseeing clinical trials and ensuring that projects are conducted in accordance with applicable standards, regulations, and guidelines.

Key Responsibilities
  • You will work as a member of the project team, contributing towards efficient management of trials.
  • You will perform site qualification visits, discussing protocol requirements with Investigators and other trial staff, ensuring that trial staff and site facilities align with protocol requirements, local regulations, and international standards.
  • You will support feasibility, site selection, and start-up activities, including leading the preparation of submissions for Human Research Ethics Committees (HRECs) at sites.
  • You will negotiate site budgets and assist with the execution of site contracts with support from the Project Manager.
  • You will perform site initiation visits, training Investigators and other trial staff in the protocol and data collection methods to ensure accurate, complete, and compliant patient data collection.
  • You will conduct interim monitoring visits, ensuring adherence to protocol, monitoring participant source data via source document verification according to the monitoring plan, and performing Investigational Product accountability, meeting with site staff to ensure study procedures are conducted in accordance with the protocol and informed consent.
  • You will conduct site close-out visits.
  • You will oversee all aspects of study site management to ensure high-quality data.
  • You will maintain electronic Trial Master File (eTMF) documentation.
  • You will manage timely site payments.
Requirements
  • You must hold an undergraduate degree in Life Sciences, such as Biology, Chemistry, or Pharmaceuticals.
  • You must have at least 3-4 years' experience in monitoring clinical trials in Contract Research Organizations (CROs), pharmaceutical, or biotechnology industries as a Senior Clinical Research Associate/Clinical Research Associate.
  • Experience in managing early-phase oncology trials is highly desirable.
  • Experience in Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) is essential.
  • Experience in all aspects of site management, from feasibility, start-up, site selection to site close-out, is required.
  • Negotiation skills, particularly in contract negotiation, are desirable.
  • Experience in preparing HREC submissions is necessary.
  • You must have a solid understanding and practical knowledge of Good Clinical Practice (GCP) requirements, particularly as required for site management.
  • You must be willing to travel to fulfill the requirements of the role.
Benefits
  • Opportunities for professional growth and development.
  • The chance to work directly with sponsors on assigned projects.
  • Internal and external training and development opportunities.
  • A range of employee benefits, including access to confidential support services and holistic wellbeing programs.

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