職位描述
Job DescriptionMain Responsibilities:
? Provide general administrative support including, but not limited to:
? Support travel and expense management for the study team if required
? Provide external and internal communication support: e-mail, fax and phone
? Organize internal and external meetings, telephone conferences, etc. and draft minutes
? If required, manage local files as applicable, e.g. maintenance of the local regulatory files as required by the local regulatory requirements and SOPs, resource training files, etc.
? Act as the contact person for CRAs in case of absence /travel
? Assist the study team as needed to support assigned projects
? Assist in clinical study set-up for administrative and logistical tasks , including preparation and/or submission of IEC/HA files
? Track invoice and follow up on payments to investigational sites if required
? Transmit, collate, track and file documents and data for the CRA/Project Team and provide alerts regarding missing information
? Act as Super User in CTMS for a country / cluster of countries, if required
? Act as the main point of contact for e translation of study documents upon request, and submit them for validation to the project team, if applicable
? Follow up on issues mentioned in the weekly study update with project team (e. g reminder to CRAs..,etc) and send regular reminders, if required
? Extract reports form clinical systems (e.g e-TMF, CTMS, IVRS) in close collaboration with the Project Team and LM
*Job Qualifications
Experience and knowledge (CMA I)
? At least 1 to 2 years' administrative experience, prior experience as Clinical Trial Assistant or similar experience with clinical trials is preferred
? Basic knowledge of GCP and the regulatory environment in the country or cluster of countries
? Basic Knowledge of medical terminology preferred
? Excellent computer skills: MSWord/Excel/PowerPoint and willing to use new advanced technologies
? Fluent in English
Behaviors
? Strong organizational skills
? Strong communication skills (verbal and written) internally and with external parties.
? Team-player but able to work independently
? Ability to recognize confidential information and maintain strict confidentiality of restricted information
? Attention to detail
? Ability to work across multiple projects at same time
? Sense of urgency and display “can do attitude”
? Systematic approach to work but able to change priorities when needed
? Continuously seeks improvement in self and in processes
? Good time management skills in order to meet deadlines
