Clinical Research Associate Team Lead

3 days ago

North Ryde, New South Wales, Australia Parexel Full time

We are seeking an experienced Clinical Research Associate I to join our team at Parexel. The successful candidate will have 1-2 years of experience in start-up activities and be open to considering experienced Study Coordinators with similar experience from a site level.

The Key Accountabilities for this role include:

Start-up (from site identification through pre-initiation):

  • Act as the direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country-specific feasibility and/or site pre-qualification and qualification activities, which may include:
    • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
    • Conduct remote Qualification Visits (QVs).
  • Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
  • Develop strategy to configure, distribute, and collect, and review and approve, high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow-up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for:
    • IRB/IEC and MoH/RA submission/approval,
    • Site activation,
    • Patient recruitment & retention.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project-specific training requirements prior to study start.
  • Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
  • Work in a self-driven capacity, with limited need for oversight.
  • Proactively keep manager informed about work progress and any issues.

This role offers a competitive salary of $60,000 - $80,000 per annum, depending on experience and qualifications.

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