Liège, Walloon Region, Belgium
* Planning - executing - and supporting clinical site management activities * Ensuring quality and integrity of data collected in sponsored clinical trials. Therapeutic areas: Oncology/ Hematology – Cardiology/Cardiovascular – Musculoskeletal – Infections (Crohn Disease) - Pediatrics Phase 2 -Phase 3 - Phase 4 Multicenter - Prospective Observational – Controlled Open label – Randomized Double blind IP Management / Administration (drug accountability and reconciliation) Working with GMO/surveillance program IPDs – product complaints – dosing deviations Conducting site feasibility/evaluation visits - monitoring onsite and remote visits (+Source DataVerification - CRF/eCRF – query handling) - close-out visits Providing training to site staff about GCP, protocol, CRF, therapeutic area, QA and compliance requirements … Follow-up on site needs and site-related issues / escalate and initiate necessary actions Writing monitoring reports – archiving of study files/documents Coordinate and maintain site supplies Working in an international study team Training and coaching of junior CRA's
HistoScanning™ by AMD, is a CE marked novel ultrasound-based application that utilises advanced tissue characterisation algorithms to visualise the position and extent of differentiated tissue, suspected of being malignant Post Marketing European Clinical Trials (UK-France-Germany-Czek Rep.-Estonia-Russia-Spain-Italy-Switzerland) dealing with the organization of the clinical trials split into 4 main levels: • pre-study level: preparation and finalization of study documentation (protocol, patient information sheet and ICF, CRF, study workflow, patients' files, etc); administrative tasks (submission/authorizations to/from the EC and CA (from each country and local laws), insurance contracts, clinical study agreement with the administration of the hospital, "special conventions", etc); • initiation level: logistic for the study equipment (scanner, contact with biomedical department at site to place it, etc), coordination for the installation and standard training, study kick-off at site • recruitment level: enter patient into the study, data collection and queries, data monitoring, data entry into database, scan review, pre-analysis (at R&D dpt.) • post-recruitment: closure of the sites (at all levels: no pending issue left), data lock, data transfer to biostatisticians, help in writing the study report and have it finalized and approved by all investigators, send the study report to all Ethical Committees, ready to start publication phase (help to abstract ->some can be written in phase 3 already – intermediary analysis, manuscript, etc). • Additionally: -> help and advises in writing the clinical evaluation (which involves writing and maintaining the clinical evaluation report and the investigator's brochure). -> maintain our SOP's up to date.
Clinical Research Director assistant & CTA o All administrative support to the Clinical Research Director o Document management and administrative support: preparation of studies, activities during and at the end of the and after study o Operational support Assistance/support for the logistic aspect of clinical studies Organise and review translations of study documents Preparation support and ad hoc attendance for the operational meetings. Preparation of submission (including electronic) package to EC Preparation of study file binders according to study requirements: ISF, Pharmacy Site File, Local Laboratory Site File, … Assist the trial team in written and oral communication with the sites, correspondence: e-mails, letters, answer phone in absence of TCMs, CMLs and CRAs…