Clinical Research Associate Specialist

5 days ago

Melbourne, Victoria, Australia beBeeResearch Full time $90,000 - $120,000
Job Overview

We are seeking a skilled Clinical Research Associate Specialist to conduct on-site monitoring visits and ensure compliance with regulatory requirements.

  • Conduct qualification, initiation, and closeout visits for research sites in accordance with approved protocols;
  • Maintain effective communication with site staff, including clinical research coordinators and physicians;
  • Evaluate investigator qualifications, training, and resources, ensuring adequate facilities, laboratories, equipment, and staff;
  • Verify accurate documentation of medical records and research data against case report forms, adhering to good documentation practices;
  • Review and verify adverse events, concomitant medications, and illnesses to ensure accurate data reporting;
  • Assess patient recruitment and retention success at clinical research sites and provide recommendations for improvement;
  • Complete monitoring reports and follow-up letters, highlighting significant findings, deviations, and recommended actions.
Requirements
  • Bachelor's degree in a health or science-related field;
  • At least 1.5 to 5 years of experience in clinical monitoring;
  • Strong knowledge of clinical monitoring practices and procedures;
  • Excellent communication and organizational skills;
  • Ability to work independently and as part of a team;
  • Proficiency in MS Office applications.

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