Senior Clinical Operations Specialist

5 days ago

Shire Of DerbyWest Kimberley, Australia beBeeResearch Full time $100,000 - $130,000

Our Mission

We are a team of professionals dedicated to accelerating research, solving complex scientific challenges, and driving technological innovation. Our work spans laboratory, digital, and decentralized clinical trial services, making a positive impact on a global scale.

As a Clinical Research Associate, you will be responsible for performing and coordinating all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.

Key responsibilities include:
  • 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. Assess investigational product 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 follow all issues through to resolution.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
  • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
  • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls, etc).

Skill Set Requirements

The ideal candidate will possess excellent clinical monitoring skills, demonstrated understanding of medical/therapeutic area knowledge and medical terminology, and effective oral and written communication skills. The ability to manage Risk Based Monitoring concepts and processes, along with strong attention to detail, is also highly desirable.

Work Environment

This home-based position requires candidates to currently live in one of the following cities: Perth or Adelaide. As a condition of employment, employees must have received their Covid-19 vaccine and disclose proof of vaccination status upon employment.

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