Site Identification Specialist (Feasibility)

at  PSI CRO

Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
We are in search of an experienced professional dedicated to developing strategic relationships with clinical research sites, with the aim of optimizing and advancing the progress of clinical trials.

QUALIFICATIONS

• 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
  Additional Information

GENERAL RESPONSIBILITIES:

• Maintain and refine internal site databases in cooperation with Study Startup, Clinical Operations and Process Improvement
• Participate in the development of improvement strategies for the site identification process, implementation thereof, as well as related training activities

PROJECT RESPONSIBILITIES:

• Define the main study objectives and the optimal site profile
• Create initial list of potential sites
• Communicate with project teams on 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 check 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