Healthcare Professional

1 week ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $118,310 - $142,466
Job Description

As a Clinical Research Monitor, you will play a crucial role in bringing our mission to life - enabling customers to make the world healthier, cleaner and safer.

  • Performs and coordinates different aspects of clinical monitoring and site management.
  • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
  • Manages procedures and guidelines from different sponsors and/or supervising environments.
  • Acts as a site processes specialist, ensuring that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs.
  • Ensures audit readiness.
Key Responsibilities:
  • 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 products through physical inventory and records review.
  • Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.

Achieves successful project delivery by implementing effective communication strategies between investigative sites, clients and the PPD project team. Develops collaborative relationships with investigational sites and participates in investigator meetings. Initiates clinical trial sites according to relevant procedures and ensures compliance with the protocol and regulatory obligations. Conducts on-site file reviews per project specifications and provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.

Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.

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