Clinical Research Associate II Biotech

4 weeks ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Job Title: Clinical Research Associate II Biotech

We are seeking a highly skilled Clinical Research Associate II Biotech to join our dynamic team. As a Clinical Research Associate II Biotech, you will be responsible for coordinating activities to set up and monitor clinical studies, ensuring adherence to applicable regulations and principles of ICH-GCP.

Key Responsibilities:
  • Coordinate activities to set up and monitor clinical studies, ensuring adherence to applicable regulations and principles of ICH-GCP.
  • Submit protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested.
  • Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.
  • Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness.
  • Dependent on level of experience, may assist in training and mentoring less expert CRAs and/or lead CRAs working on international projects.
Requirements:
  • 2-3 years+ of independent monitoring experience in phase I-III trials as a CRA at a CRO.
  • Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data.
  • Excellent written and verbal communication in English.
  • Ability to produce accurate work to tight deadlines within a pressurized environment.
  • Remote except for monitoring in which you will travel as per below.
  • Will be asked to travel at least 8-10 days onsite and 2-3 overnights a week (international and domestic - fly and drive) and should possess a valid driving license.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

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