Senior Clinical Research Professional

4 days ago

Rockhampton, Queensland, Australia beBeeCareer Full time $90,000 - $115,000
Job Summary

We are seeking a seasoned professional to join our clinical research team as a Senior Clinical Research Associate. In this role, you will play a pivotal part in driving the success of clinical trials.

About the Role

This is an exciting opportunity to work on monitoring clinical trials, ensuring projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.

  • As a member of the project team, you will contribute towards efficient trial management.
  • You will perform site qualification visits, discussing protocol, study documentation, and requirements with investigators and trial staff.
  • Support feasibility, site selection, and start-up activities, including preparing Human Research Ethics Committee submissions.
  • Negotiate site budgets and assist with contract execution.
  • Perform site initiation visits, training investigators and trial staff on protocols and data collection methods.
  • Conduct interim monitoring visits, ensuring adherence to protocols and source document verification.
  • Perform site close-out visits and oversee all aspects of study site management.
Requirements

To succeed in this role, you must have:

  • An 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 industries as a CRA/SCRA.
  • Experience in managing early phase oncology trials is highly preferred.
  • Knowledge of EDC & CTMS, contracts negotiation, and HREC submission preparation.
  • Understanding and practical knowledge of ICH-GCP requirements.
What We Offer

Joining our team offers numerous benefits, including:

  • Opportunities for personal development and growth.
  • Exposure to early site engagement and relationship-building opportunities.
  • Collaboration with sponsors on assigned projects.
  • Internal and external training and development programs.
  • Access to confidential support services, including financial, nutritional, and wellbeing coaching.
  • A comprehensive wellbeing program.
  • Range of benefits.

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