Abbott Clinical Study Assistant - temporary 12 months in Rome, Italy
ROLES & RESPONSIBILITIES
Full compliance to Abbott Medical Clinical SOP in terms of Clinical study submission, organization and archiving
Support the production and timely submission of documents requested for Ethical Commissions and Competent Authority.
Interaction with Ethics Committee for check and ship documents in due date for meetings
Update SMF (Study Master File) and local intranet for study's documentation
Be a front line interface with external services, Study Investigators, Ethics Committees
Prepare patient binders for clinical studies
Regular shipment of forms-binder-updates of studies to Clinical Dep/FTEs/Sales Rep for clinical studies and/or to Centers and Investigators active in Abbott Medical studies
Follow up studies updating in Excel files
Support studies related activities and reporting to improve data quality and follow-up management
Support the creation of Study Newsletter, Study Weekly Updates and Clinical Department Newsletter
Regular shipment and tracking of the study CRFs (Case Report Forms) to Brussels
Occasional activities such as data entry of local studies
Support data base creation and statistical analyses for local studies
Support the management of CLOUD projects in term of documents preparation for service approval in the centers, data transfer/entry and compliance analyses.
Responsibilities for all functions:
This job description is intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities.
When tasks and responsibilities are assigned outside the scope of normal duties, the employee must understand the level of decision making for which he/she is responsible and if in doubt clarify this with his/her supervisor.
EDUCATION & COMPETENCIES
School or University qualifications
Medical/biomedical/bioengineer/bioscience background (MS/Engineer/PhD/MD, etc) or relevant previous experience
Knowledge and skills (e.g. languages, PC, …)
Good knowledge of English, both written and verbal.
Good knowledge of Office programs.
Natural abilities (teamplayer, stress resistant, discretion, good communicator, etc.)
Personal Involvement and ability to work on multiple projects
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com