Clinical Research Officer — IBSA Institut Biochimique
NewCHF 85'500 - 150'000
IBSA Institut Biochimique · Collina d'Oro (TI)
- Location
- Collina d'Oro
- Contract
- internship
- Posted
- 3 days ago
SalaryCHF 85'500 - 150'000
Role overview
The resource will provide support to the Clinical Research Manager (CRM) in the administrative and operational aspects of preclinical and clinical studies in all their stages, in accordance with the internal SOPs, in order to ensure the correct start, development and completion of clinical trials.
- The resource will provide support to the Clinical Research Manager (CRM) in the administrative and operational aspects of preclinical and clinical studies in all their stages, in accordance with the internal SOPs, in order to ensure the correct start, development and completion of clinical trials.
Company and context
- Trial Master File (TMF) The main activity concerns the organization and maintenance of the Trial Master File (TMF) through the management and archiving of the study documentation in both paper and electronic format. Paper TMF (pTMF) Setup of pTMF;
- Check (quality check) and storage of the study documentation;
- Periodic checks of completeness of the TMF during the study and recovery of the documentation to be stored;
- Maintenance of the TMF Workbook (PCRS TMF documents tracker);
- Upload of all TMF documentation on SharePoint to maintain an electronic version of the TMF;
- At the end of the study, verification and union of paper collectors for final storage;
- Final verification of TMF completeness before archiving. IBSA electronic TMF (Veeva)
- Preparation of the TMF Plan and study setup in Veeva (Expected Documents List) in collaboration with CRM;
- Periodic checks of completeness of eTMF during study and recovery of documents to be uploaded; Periodic activity of eTMF oversight;
- Active role in drafting and reviewing documents within the system;
Additional details
- Trial Master File (TMF) The main activity concerns the organization and maintenance of the Trial Master File (TMF) through the management and archiving of the study documentation in both paper and electronic format.
- Final verification of TMF completeness before archiving. IBSA electronic TMF (Veeva)
- Periodic checks of completeness of eTMF during study and recovery of documents to be uploaded; Periodic activity of eTMF oversight;
- Support and collaboration with CROs for the operational use of eTMF; Other eTMF provider (repository eTMF)
- Final verification of eTMF completeness before archiving. Operational activities in clinical studies
- Organization of shipment of reference samples of clinical trials (when applicable) to EU QP;
- Participation in the periodic meetings of the study teams. Other activities within PCRS
Notes and original content
- Paper TMF (pTMF)
- Setup of pTMF;
- Final verification of TMF completeness before archiving.
- IBSA electronic TMF (Veeva)
- Periodic checks of completeness of eTMF during study and recovery of documents to be uploaded;
- Periodic activity of eTMF oversight;
- Support and collaboration with CROs for the operational use of eTMF;
- Other eTMF provider (repository eTMF)
- Final verification of eTMF completeness before archiving.
- Operational activities in clinical studies
