Clinical Trial Administrator I

3 weeks ago


King of Prussia Pennsylvania, United States PSI CRO Full time
Job Description

Site Management

Under supervision, exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team

Under supervision, may assist with clinical supplies (including medication) order, receipt, inventory storage, distribution, return/recall and reconciliation

Under supervision, supports CA submissions and notifications

Under supervision, assists with handling administrative financial tasks

 Under supervision, may assist with preparation and follow-up of site, TMF and systems´ audits and inspections

Other Communication

Under supervision, exchanges data, documents, and other information with the project team and other departments

Under supervision, provides assistance with organization of internal team meetings

Under supervision, prepares draft minutes of internal team meetings

 Under supervision, assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicable

Under supervision, maintains study-specific and corporate tracking systems

Document Management

Under supervision, maintains Trial Master File (TMF)

Under supervision, may perform TMF review and oversight at country and site level

Under supervision, prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists

Under supervision, provides assistance with translations

Safety Management

Under supervision, may assist with safety information flow between investigative sites and the project team

Corporate/Departmental Assignments

Under supervision, may provide administrative assistance with feasibility research

Other Assistance

Provides miscellaneous administrative project support (if applicable)



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