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Lead Research Monitor

2 weeks ago

Perth, Western Australia beBeeClinicalResearch Full time $100,000 - $125,000
Senior Clinical Research Associate Job Description

The Senior Clinical Research Associate plays a pivotal role in the success of clinical trials. This position involves conducting site management and monitoring activities to ensure the quality and integrity of our studies.

 

About the Role:

  • Conduct remote or on-site visits to assess protocol and regulatory compliance
  • Manage required documentation and ensure audit readiness
  • Develop collaborative relationships with investigational sites
  • Monitor investigator sites with a risk-based monitoring approach and identify site processes failure and corrective/preventive actions
  • Ensure data accuracy through SDR, SDV and CRF review as applicable
  • Participate in the investigator payment process and ensures shared responsibility with other project team members on issues/findings resolution
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required

 

Requirements:

  • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent
  • Previous experience as a clinical research monitor (comparable to 3+ years)
  • Minimum 2 years Oncology monitoring experience
  • Valid driver's license
  • Australian Citizen or Permanent Resident only

 

Key Skills and Qualifications:

  • Effective clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
  • Critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
  • Risk Based Monitoring concepts and processes
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

 

We Value Your Health:

We care about the well-being of our employees. We strive to create a healthy work environment where you can thrive.

 

This role requires independent travel up to 80%. You will be responsible for traveling in automobiles, airplanes, and trains. Overnight travel is also a requirement for this position, depending on business needs.

 

As a condition of employment, you must have received your Covid-19 vaccine and provide proof upon employment.

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