Clinical Study Activation Coordinator

1 week ago

Sydney, New South Wales, Australia beBeeSite Full time $70,000 - $90,000
Job Description

As a key member of our project team, you will serve as the Single Point of Contact (SPOC) for assigned studies. Your primary responsibility will be to perform start-up and site activation activities in accordance with applicable regulations, Standard Operating Procedures (SOPs), and work instructions.

Key Responsibilities:

  • Perform site initiation and site activation activities in accordance with applicable regulations, SOPs, and work instructions.
  • Provide local expertise to the Project Management team during initial and ongoing project timeline planning phases.
  • Prepare and review ethics and regulatory documentation ensuring completeness and accuracy.
  • Monitor and track progress, approval, and execution of various documents such as questionnaires, regulatory submissions, ethics approvals, Informed Consent Forms (ICFs), and Investigator Pack (IP) release documents.
  • Review, prepare, and negotiate study budgets and contracts with sites ensuring accurate maintenance of internal systems, databases, and tracking tools.
  • Conduct quality control of documents provided by sites obtaining necessary documentation and approvals.
  • Handle maintenance activities such as site budget and contract amendments.
  • Review site performance metrics and provide feedback to management based on observations and analysis.
Requirements

To be successful in this role, you should have the following qualifications and skills:

  • Bachelor's Degree in Life Sciences or equivalent work experience.
  • 0 - 2 years' experience Clinical Research or Site Start-Up within a CRO/Pharmaceutical Company ideally in Australia/New Zealand.
  • Knowledge of clinical systems, procedures, and corporate standards.
  • Good communication skills ability to negotiate and problem solve.
  • Good interpersonal and organisational skills.
  • Ability to work on multiple projects balancing competing priorities.
  • Willingness to learn and embrace emerging technology.

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