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Site Development Specialist

2 months ago

Sydney, New South Wales, Australia PSI Full time

Job Overview

PSI is seeking an experienced professional to develop strategic relationships with clinical research sites, with the aim of optimizing and advancing the progress of clinical trials.

Key Responsibilities:

  • Maintain and refine internal site databases in collaboration with Study Startup, Clinical Operations, and Process Improvement teams.
  • Participate in the development of improvement strategies for the site identification process, implementation thereof, and related training activities.
  • Project Responsibilities:
    • Define the main study objectives and the optimal site profile.
    • Create an initial list of potential sites.
    • Communicate with project teams on a project/regional level to fine-tune strategy and methodology of initial and follow-up site contacts depending on indication, regional specifics, and technologies in use.
    • In cooperation with the project team, maintain a study site identification tracker for further site evaluation and selection activities.
    • Liaise with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives.
    • In cooperation with Legal, perform due diligence checks of regulatory and legal limitations applicable to the recommended investigators or clinical sites.
    • Support the project team throughout study startup and further on, whenever additional rounds of site identification are necessary, and/or additional information on the site/investigator is needed.

Requirements:

  • University/college degree (Life Sciences/Pharmacy/RN/Healthcare field is a plus), or an equivalent combination of education, training, and experience.
  • Minimum 2 years of proven prior experience in Site Identification/Study Start-Up activities or equivalent.
  • Understanding of Good Clinical Practice, local laws, and applicable regulations in Australia.
  • Communication and collaboration skills.
  • Demonstrated ability to work in a dynamic environment, under compressed deadlines across several projects, each with unique requirements.

What We Offer:

  • Excellent, flexible working conditions.
  • Extensive training and supportive team.
  • Competitive salary and benefits package.

At PSI, we prioritize our employees' ongoing professional growth and success, and we're committed to investing in their development.