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Overview
Provides project administrative support, manages documents, study-specific trackers, liaises with study vendors and members of the project team.
This function operates at site and country level and may be assigned as a Support Project Assistant to clinical trial projects.
Responsibilities
1. Study administration support
1.1. Exchanges project-specific information and documents with other PSI departments, sites and vendors
1.2. Maintains information in study-specific and corporate tracking systems
1.3. Supports regulatory and ethics committee submissions and notifications
1.4. Assists with organization of internal team meetings
1.5. Under supervision, coordinates sites payments within the project team
1.6. Under supervision, prepares draft agendas for, and minutes of, internal team meetings
1.7. Under supervision, assists with preparation, conduct and follow-up of Investigator Meetings
1.8. Assists with clinical supplies order, receipt, inventory storage, distribution, return/recall and reconciliation at either PSI warehouse or as defined by the project team
1.9. Assists with preparation for and follow-up on TMF and systems audits and inspections
2. Document Management
2.1. Under supervision maintains, performs regular periodic checks of, and files study related documents in the TMF on a site and country level
2.2. Under supervision prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
2.3. Assists with translations of study-specific documents
3. Safety Management
3.1. Under supervision, assists with safety information flow with investigative sites
3.2. Other departmental assignments, as necessary
Requirements
Bachelor's and above Degree in Medicine, Pharmacy and relevant Life Sciences major
Well-developed communication and organizational skills