Clinical Research Professional

1 week ago

Sydney, New South Wales, Australia beBeeClinical Full time $90,000 - $110,000
Job Title: Clinical Monitoring Specialist

We are seeking a skilled Clinical Monitoring Specialist to join our team. The successful candidate will be responsible for conducting site visits, monitoring trial progress, and ensuring compliance with regulatory requirements.

This is a home-based position and preferably based in Melbourne, Sydney or Brisbane.

  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
  • Assesses investigational product through physical inventory and records review.

The ideal candidate will have a Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification. Minimal 1-2 year's clinical monitoring experience that provides knowledge, skills, and abilities to perform the job in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research, or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.

Required Skills and Qualifications:

  • Basic medical/therapeutic area knowledge and understanding of medical terminology.
  • Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents.
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel.

Benefits:

  • Competitive remuneration package.
  • Annual incentive plan bonus.
  • Employee benefits.

Work Environment:

  • Home-based position.
  • Preferably based in Melbourne, Sydney, or Brisbane.

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