Senior Clinical Study Coordinator

2 weeks ago

Sydney, New South Wales, Australia beBeeResearch Full time $100,000 - $120,000

Clinical Research Associate Job Summary:

This Clinical Research Associate position is responsible for ensuring the overall integrity of study implementation and adherence to study protocol.

Key Responsibilities:

  • Maintenance from initiation through close out:
    • Act as direct contact with assigned sites
    • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant
  • Build relationships with investigators and site staff
  • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements
  • Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable
  • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements
  • Conduct remote visits/contacts as requested/needed
  • Generate visit/contact report
  • Perform problem-solving to address and resolve site issues

Overall Accountabilities from Site Identification to Close Out:

  • Ensure timely and accurate completion of project goals and update of applicable trial management systems
  • Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required
  • Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS)

Required Skills and Qualifications:

  • Sound problem solving skills
  • Able to take initiative and work independently, and to proactively seek guidance when necessary
  • Advance presentation skills
  • Client focused approach to work
  • Ability to interact professionally within a client organization
  • Flexible attitude with respect to work assignments and new learning
  • Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise

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