- Contribute country specific aspects in the development of protocol, protocol revisions, amendments and CRF design.
- Responsible for the management of designated sites in clinical trial including:
- Site assessment
- Preparation of the monitoring plan and execution in compliance with visit frequency and all assigned
- Planning and execution of study logistics plan, including eventual delegation of activities to support
- Safety and proper conduct throughout the trial
- Site specific data management
- Prepare documentation for IRB/EC submission/approval, together with study management per country specific requirements.
- Prepare and review clinical study agreements and budgets with study manager and contracts group.
- Ensure procedures are in place for appropriate enrollment of patients into the clinical trial.
- Organize investigator's start-up meeting and study site initiation meetings, including training of the external study personnel in the use of the instruments and reagents and software packages for the on-line data capture and for the computer based e.g. with WINCAEV and training in the use of electronica CRFS with remote data entry.
- Responsible for instrument installation, check and validation (internal and external) for system study. If applicable, prepare workflow sheet for system studies, together with study management.
- Responsible for logistics of required evaluation/clinical trial material.
- Informs and monitors sites for correct storage conditions.
- Preparation of all study binders
- Perform investigator training (compliance & technical part).
- Verify the investigator follows the approved protocol and all GCP procedures.
- Verify all research staff and facilities have adequate qualifications and resources remain adequate throughout the duration of the study.
- Key contact for communications between the sponsor and the investigator; the point of first contact when investigators/site personnel enquirer about patient inclusion/exclusion criteria for ongoing trials.
- Ensure that observations during studies are correctly tracked and forwarded to the responsible departments
- Verify that source data/documents and other trial records are accurate, complete, and maintained. Regarding the result calculations: ensure the usability of validated computer programs/software and result calculation in compliance to applicable sops.
- Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator.
- Interprets and evaluates results with respect to the study goals and, if necessary, discuss with the site, the study manager, eg. Interruption of the study or initiation of additional measurements at the external site.
- Ensure completion and availability of study documentation, together with study management
- Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol.
- Conduct study close-out visits according to monitoring plan.
- Ensure ECRF and WINCAEV are ready for database lock.
- Archive study records / database according to guidelines.
- Responsible for post study sample/reagents/investigational use products/instruments disposition completed during the close-out visit.
- Participation in project teams, global conference calls and/or meetings to review progress of ongoing clinical trials and to assess development of new projects regarding customer usability, practicability and sop tasks throughout the study group
Bachelor’s Degree in Nursing or related field