Clinical Trial Administrator I

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)