Senior Clinical Trials Specialist

1 week ago

Sydney, New South Wales, Australia beBeeClinicalResearchAssociate Full time $120,000 - $140,000
Job Title: Senior Clinical Research Associate

We are seeking a seasoned professional to fill this pivotal role in the management of clinical trials.

The ideal candidate will be responsible for ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.

Key responsibilities include:

  • Collaborating with project teams to ensure efficient trial management.
  • Conducting site qualification visits, discussing protocol and study requirements with investigators and trial staff.
  • Spearheading feasibility, site selection, and start-up activities, including leading the preparation of HREC submissions.
  • Negotiating site budgets and assisting with the execution of site contracts.
  • Conducting site initiation visits, training investigators and trial staff in the protocol and data collection methods.
  • Performing interim monitoring visits, ensuring adherence to protocol and monitoring participant source data.
  • Overseeing all aspects of study site management to ensure high-quality data.

Requirements:

  • Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
  • A minimum of 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.
  • Proficiency in EDC & CTMS.

Successful candidates will possess excellent communication skills, a strong attention to detail, and the ability to work effectively in a team environment.

This is an exciting opportunity for individuals looking to take on new challenges and contribute to the success of our organization.

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