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.)

  • Teamwork

  • Personal Involvement and ability to work on multiple projects

  • Initiative

  • Stress resistance

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 corpjat@abbott.com