Site Identification Specialist

PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Based in Shanghai

Overall Responsibilities

- Maintains and refines the internal site database in cooperation with Study Startup, Clinical Operations and Process Improvement.

- Participates in development of improvement strategies for the site identification process, implementation thereof, as well as related training activities. Project Responsibilities

- Upon assignment to an awarded study, liaises with Project Management and Study Startup specialists as well as other functions involved to define the main study objectives and the optimal site profile.

- Creates the initial list of potential sites.

- Communicates with project teams on project/ regional level to fine-tune strategy and methodology of initial and follow-up site contacts depending on indication, regional particularities, and technologies in use.

- In cooperation with the project team maintains a study site identification tracker, or an analog thereof, for further site evaluation and selection activities.

- Liaises 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, performs due diligence check of regulatory and legal limitations applicable to the recommended investigators or clinical sites.

- Participates in project team meetings during study startup, as needed.

- Supports 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.

- Bachelor's and above Degree in Medicine, Pharmacy and relevant Life Sciences major.

- Minimum 2 years of experience in site identification/ study startup activities.

- Excellent knowledge of ICH GCP, local laws and applicable regulations in the region.

- Fluent in oral English.

- Well-developed communication and organizational skills.

- Ability to negotiate and build relationships at all levels.

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