We are hiring! Clinical Trial Assistant (CTA)

Line ManagerCoordination Center of INCIPIT (key reference roles:  Senior Scientific Managers)
Principal AccountabilitiesTo provide  support to the general activities handled by the INCiPiT Coordinating Center Team, in terms of:
– Financial tracking (invoicing, finalization of Work Orders, ad hoc contracts, tracking of the administrative activities of the NHs involved in the c4c project/studies)
– Tracking of the agendas of pre-defined meetings/commitments and organization of ad hoc meetings, as per specific Team involvement
– Distribution of materials to Operative Teams, Study Teams and or Scientific Teams
– Support the activities of INCiPiT Working Groups, as requested
– Support the interactions with local INCiPiT referees, also to retrieve specific information.
– Bridging with CROs and/or Sponsors to support specific activities, such as: study scientific/operational feasibilities, identification of local costs and finalization of study budgets, identification of the local correct stakeholder for contract negotiations.
– Support the internal CRAs and/or the Clinical Project Manager (CPM)  in performing the regulatory mapping for a clinical study/clinical project
– Supervise the flow of regulatory documentation from the NHs to the allocated vendor for TMF/ISF management (therefore to supervise the specific activity when allocated on the internal regulatory resource)
– Perform directly any regulatory submission (when requested by the Sponsor) and maintain contacts with Regulatory Authorities and/or Ethics Committees.  
Professional Background and Experience– Scientific Degree in Science
– Research or health care related academic or work experience
– From 2 to 3 years of experience in Clinical Trials coordination and or Clinical Development activities and a minimum of one (I) year of administrative experience (or equivalent training)
Technical Competencies– Knowledge of GCPs and of Regulatory/ethics obligations, laws and regulations for clinical trials/clinical development management
– Very good Knowledge of the main Office software (Word, Excel, Power Point, etc.)
– Capability to get quick familiarity with CTMSes and databases, research dedicated
– Good knowledge of quality systems and quality assurance assets
General Competencies– Professional  Knowledge of English, both spoken and written
– Very good organizational skills, ability to manage multiple tasks and meticulous attention to detail
– Very good time management skills
– Very good written and verbal communication skills
– Advanced ability and attitude on team working ad in particular good capability to work in a matrix environment
Salary   To be discussed during the interview. Benchmarking with the present position as defined in academic organizations is proposed.