Full TimeENAsia/Pacific
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.
SCOPE OF RESPONSIBILITIES
1. Overall responsibilities
1.1. Is responsible for the growth of PSI's site network in the assigned country/region.
1.2. Establishes relationship with sites new to PSI and strengthens partnership with existing sites and networks.
1.3. Maintains and refines the internal site database in cooperation with internal and external parties.
1.4. Attends conferences with the aim to expand PSI's investigator network.
2. Project responsibilities
2.1. Develops site profile and creates the initial list of potential sites.
2.2. Defines strategy and methodology of initial and follow-up site contacts depending on indication, regional particularities, and technologies in use.
2.3. Identifies potential risks or issues to country and site feasibility.
2.4. Tracks site identification activity through applicable systems.
2.5. Facilitates Confidentiality Agreement (CDA) execution and Site Identification Questionnaire (SIQ) completion with Investigators and sites.
2.6. Files signed CDAs and completed questionnaires in the project eTMF.
2.7. Participates in project team meetings during study startup.
2.8. 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.
2.9. If assigned, prepares, conducts and reports site selection visits in the country/region.
2.10. Communicates with investigators and analyses study feasibility for Strategic Feasibility.
- Bachelor's and above Degree in Medicine, Pharmacy and relevant Life Sciences major.
- Minimum 2 years of experience in site identification/ study startup activities.
- Knowledge of ICH GCP, local laws and applicable regulations in the region.
- Fluent in oral English.
- Well-developed communication and organizational skills.
- Proficiency in standard MS Office applications.
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