Clinical Trial Manager

3 days ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $122,830 - $229,523
Senior Clinical Research Associate Job

We are seeking a skilled professional to fill the role of Senior Clinical Research Associate. As a key member of our team, you will be responsible for overseeing clinical trials and ensuring that projects are conducted in accordance with relevant standards, regulations, and guidelines.

About the Role
  • This is an exciting opportunity to work on various clinical trials, contributing towards efficient project management.
  • You will perform site qualification visits, discussing protocol and study documentation with investigators and trial staff.
  • Your responsibilities will also include supporting feasibility, site selection, and start-up activities, including preparing submissions for Human Research Ethics Committee review.
  • You will negotiate site budgets and assist with contract execution.
  • Additionally, you will conduct site initiation visits, training investigators and trial staff in protocol and data collection methods.
  • Interim monitoring visits will involve ensuring adherence to protocol and verifying participant source data.
  • Finally, you will complete site close-out visits.
Requirements
  • A bachelor's degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) is required.
  • A minimum of 3-4 years of experience in monitoring clinical trials, preferably in the CRO, Pharmaceutical, or Biotechnology industry as a SCRA/CRA, is necessary.
  • Experience in managing early-phase oncology trials is highly desirable.
  • Familiarity with EDC and CTMS systems is essential.
  • You should have experience in all aspects of site management, from feasibility and start-up to site close-out.
  • Negotiation skills and knowledge of HREC submission preparation are valuable assets.
  • Understanding and practical knowledge of ICH-GCP requirements, particularly for site management, are crucial.
Benefits
  • Opportunities for personal growth and development are available.
  • You will be exposed to various aspects of site engagement, from feasibility to close-out.
  • Direct interaction with sponsors on assigned projects is possible.
  • Ongoing training and development opportunities will support your career advancement.

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