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
- 2 days ago
SalaryCHF 85'500 - 150'000
Role overview
The resource will provide support to the Clinical Research Manager (CRM) in administrative and operational aspects related to preclinical and clinical studies in all their phases, in accordance with internal SOPs, in order to ensure the correct start, conduct, and completion of clinical trials.
Trial Master File (TMF) The main activity involves organizing and maintaining the Trial Master File (TMF), through the management and archiving of study documentation in both paper and electronic format. Paper TMF (pTMF) Setup of the pTMF
Verification (quality check) and archiving of study documentation
- The resource will provide support to the Clinical Research Manager (CRM) in administrative and operational aspects related to preclinical and clinical studies in all their phases, in accordance with internal SOPs, in order to ensure the correct start, conduct, and completion of clinical trials.
- Trial Master File (TMF) The main activity involves organizing and maintaining the Trial Master File (TMF), through the management and archiving of study documentation in both paper and electronic format. Paper TMF (pTMF) Setup of the pTMF
Company and context
- Contacts with the Product Development Department for details of packaging, approval of label proofs, organization of the transfer of study products for secondary packaging and delivery to the PCRS warehouse
- Preparation of shipments of study products and updating of relevant data in the IBSA ERP system, in collaboration with the warehouse supervisor and the team
- Contacts with the Shipping Department for the shipment of study products and related materials (if applicable) to clinical centers or to CROs/distributors, with support in the finalization of study shipment documents
- of the shipment of reference samples of clinical studies (when applicable) to the EU QP
- Constant updating of the Excel inventory file related to study products and reference samples stored in the PCRS warehouse and, in collaboration with the warehouse supervisor and the team, organization of the disposal of expired products and the allocation of new study products
- Verification of invoices received from CROs, clinical centers, distributors, and other suppliers or service providers and monitoring of the costs of clinical studies
- Insertion and tracking in the SAP system of invoices related to clinical studies or consulting agreements; contacts with the Accounting Department for monitoring the status of payments
- Participation in periodic team study meetings Other activities within PCRS
- Active role in the review of Standard Operating Procedures (SOPs) and participation in related internal meetings
- Active role in the preparation and updating of Working Instructions
Additional details
- Trial Master File (TMF) The main activity involves organizing and maintaining the Trial Master File (TMF), through the management and archiving of study documentation in both paper and electronic format.
- Final verification of the completeness of the TMF before archiving IBSA electronic TMF (Veeva)
- Periodic completeness checks of the eTMF during the study and retrieval of documents to be uploaded Periodic oversight activities of the eTMF Other eTMF provider (repository eTMF)
- Final verification of the completeness of the eTMF before archiving Operational activities in clinical studies
- Organization of the shipment of reference samples of clinical studies (when applicable) to the EU QP
- Participation in periodic team study meetings Other activities within PCRS
Notes and original content
- Paper TMF (pTMF)
- Setup of the pTMF
- Final verification of the completeness of the TMF before archiving
- IBSA electronic TMF (Veeva)
- Periodic completeness checks of the eTMF during the study and retrieval of documents to be uploaded
- Periodic oversight activities of the eTMF
- Other eTMF provider (repository eTMF)
- Final verification of the completeness of the eTMF before archiving
- Operational activities in clinical studies
- Participation in periodic team study meetings
