Clinical Research Officer
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 - Periodic completeness checks of the TMF during the study and retrieval of documentation to be archived - Maintenance of the TMF Workbook (PCRS TMF documents tracker) - Upload of all TMF documentation to SharePoint for the maintenance of an electronic version of the TMF - At the end of the study, verification and merging of paper binders for final archiving - Final verification of the completeness of the TMF before archiving ### IBSA electronic TMF (Veeva) - Preparation of the TMF Plan and study setup in Veeva (Expected Documents List) in collaboration with the CRM - Verification (quality check) and archiving of study documentation - Periodic completeness checks of the eTMF during the study and retrieval of documents to be uploaded - Periodic oversight activities of the eTMF - Active role in the drafting and reviewing of documents within the system - Quality check of documents uploaded by third parties (CRO, etc.) - Support and collaboration with CROs for the operational use of the eTMF - Final verification of the completeness of the TMF before archiving ### Other eTMF provider (repository eTMF) - Preparation of the TMF Plan in collaboration with the CRM - Verification (quality check) and archiving of study documentation - Periodic completeness checks of the eTMF during the study and retrieval of documents to be archived - Quality check of documents uploaded by third parties (CRO, etc.) - Maintenance of the TMF Workbook (PCRS TMF documents tracker) - Final verification of the completeness of the eTMF before archiving ## Operational activities in clinical studies - Support to the CRM in the finalization of study documentation for regulatory submissions and related follow-up - Correspondence with CROs and clinical centers and support in daily operational activities - Contacts with external brokers for insurance-related matters (patient liability insurance policies, any contractual changes, final settlement at the end of the study) - Contacts with the Global Supply Chain Department and/or external suppliers for the purchase of Reference Drugs and Auxiliary Medicinal Products (AMPs), such as rescue medications or other treatments prescribed by the study protocol, in support of IMPs/IMDs - Support to the CRM in the preparation and finalization of requests for the packaging of study drugs and related attachments (labelling, instructions, etc.) - 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 - Organization 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 - Participation in periodic team CTA meetings for updating, coordinating activities, and supporting/forming new team members - Current use of IT tools (DocuSign, Adiuto, SharePoint, Teams, Guest Registration, ERP codes, etc.) - Other general secretarial activities in support of the PCRS group
Description
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 - Periodic completeness checks of the TMF during the study and retrieval of documentation to be archived - Maintenance of the TMF Workbook (PCRS TMF documents tracker) - Upload of all TMF documentation to SharePoint for the maintenance of an electronic version of the TMF - At the end of the study, verification and merging of paper binders for final archiving - Final verification of the completeness of the TMF before archiving ### IBSA electronic TMF (Veeva) - Preparation of the TMF Plan and study setup in Veeva (Expected Documents List) in collaboration with the CRM - Verification (quality check) and archiving of study documentation - Periodic completeness checks of the eTMF during the study and retrieval of documents to be uploaded - Periodic oversight activities of the eTMF - Active role in the drafting and reviewing of documents within the system - Quality check of documents uploaded by third parties (CRO, etc.) - Support and collaboration with CROs for the operational use of the eTMF - Final verification of the completeness of the TMF before archiving ### Other eTMF provider (repository eTMF) - Preparation of the TMF Plan in collaboration with the CRM - Verification (quality check) and archiving of study documentation - Periodic completeness checks of the eTMF during the study and retrieval of documents to be archived - Quality check of documents uploaded by third parties (CRO, etc.) - Maintenance of the TMF Workbook (PCRS TMF documents tracker) - Final verification of the completeness of the eTMF before archiving ## Operational activities in clinical studies - Support to the CRM in the finalization of study documentation for regulatory submissions and related follow-up - Correspondence with CROs and clinical centers and support in daily operational activities - Contacts with external brokers for insurance-related matters (patient liability insurance policies, any contractual changes, final settlement at the end of the study) - Contacts with the Global Supply Chain Department and/or external suppliers for the purchase of Reference Drugs and Auxiliary Medicinal Products (AMPs), such as rescue medications or other treatments prescribed by the study protocol, in support of IMPs/IMDs - Support to the CRM in the preparation and finalization of requests for the packaging of study drugs and related attachments (labelling, instructions, etc.) - 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 - Organization 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 - Participation in periodic team CTA meetings for updating, coordinating activities, and supporting/forming new team members - Current use of IT tools (DocuSign, Adiuto, SharePoint, Teams, Guest Registration, ERP codes, etc.) - Other general secretarial activities in support of the PCRS group