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Clinical Trial Assistant - Categorie Protette
Milano e provincia
- Clinical Trial Assistant - Categorie Protette
- Inglese Fluente
Il nostro cliente
Global CRO is hiring
La figura ricercata
- To improve the Project of the Clinical Operations Department and support to Project Manager(s) and Project Director(s).
- To follow the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
- To support the Clinical Operations teams with ongoing conduct of studies.
- *To be familiar with ICH GCP, appropriate regulations, relevant SOP's and internal tracking systems.
- To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
- To manage study specific documentation and guidelines as appropriate.
- *To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
- *To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
- *To follow in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- *To partecipate project teams with trial progress tracking by updating the Clinical Trial Management systems.
- *To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
- *To manage the tracking and distribution of safety reports.
- To support the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
- Other duties as assigned
Il candidato prescelto
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (US only)
- Research or health care related academic or work experience preferable.
- Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Good written and verbal communication skills.
- Good written and spoken English.
- Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
- Willingness to travel for job related activities if required (expected travel for this position is < 10%).
Cosa comprende l'offerta
Ottima opportunità di carriera.