Clinical Trials Manager

1 week ago

Sydney, New South Wales, Australia beBeeCancer Full time $90,000 - $120,000

Senior Clinical Research Associate Role

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

About the Role:

  • Monitor clinical trials, ensuring adherence to protocol requirements, local regulations, ICH-GCP, and GC CRO's SOPs.
  • Support feasibility, site selection, and start-up activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions with sites.
  • Negotiate site budgets and assist with the execution of site contracts with support from Project Managers.
  • Perform Site Initiation Visits: train Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements.
  • Perform Interim Monitoring Visits: ensure adherence to protocol, monitor participant source data via source document verification per the monitoring plan, and perform Investigational Product accountability.
  • Oversee all aspects of study site management to ensure high-quality data.
  • Maintain eTMF filing and study tracking in Clinical Trial Management System (CTMS) in a timely manner.

Requirements:

  • An Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
  • At least 3-4 years' experience in monitoring clinical trials in CRO (preferable), 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.
  • Willingness to travel to fulfill the requirements of the role.

Benefits:

  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.
  • A competitive salary and benefits package.

About Us:

We are 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 be part of a team that makes a difference in people's lives.

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