Managing the execution of assigned protocols (from start up to close out activities), under the responsibility of the Principal Investigator & act as the main interface (Point of Contact) between the Study Teams and the Clinical Departement.
Participation in study coordination activities of the Clinical Department: maintain effective communication (facilitating meetings, ensure clarity of process and communication,...), deal with project planning and budgeting (tracking timelines/money/resources), , collect study data, manage CRF design/data quality & consistency, etc...
Ensure that the assigned clinical trials are carried out properly following ICH GCP, scientific, medical, and ethical principles, within regulatory requirements/guidelines, and standard operating procedures and following the recommendations of Head of Study Coordination.
Working with the Clinical Department study team for the management of the day to day activities of the studies, including immediate & long term problem solving, communication and protocol adherence
Supporting Principal Investigator, Project Manager and clinical department in the unit
Ensuring close follow up on clinical activities for assigned protocols
Contributing to the development of study conduct tools and providing expertise with respect to specific protocol assessments
Reviewing and providing input on protocols; interpreting protocol details and organizing study activities including the creation of study documents
Developing and improving technical capabilities and competencies necessary for clinical conduct of studies in the Clinical Department (e.g., drug administration, clinical/physiological measurements, sample collection/processing, basic nursing care, emergency care)
Performing ongoing & regular quality reviews of the data for achieving audit-readiness and meeting deadlines
Performing informed consent sessions in both languages (Fr & English) and administering informational tools to assist volunteers with study comprehension and compliance
Solving queries specific to subject data collection
Overseeing the collection and documentation of electronic and/or written study data;
Participation in QC of study set up in the electronic data capture system for protocols according to protocol requirements, Clinical Department SOP’s, and standardized processes, as appropriate collaboration with the PI to include subjects for eligibility using protocol inclusion/exclusion criteria
Assisting in study design for feasibility, implementation, and reporting of clinical trials
Languages : FR – ENGL
Synthetic minded - Ability to give training (Training background is an asset)
Presentation skills - very good communication skills
Maturity – Stress resistant
Accuracy – rigorous
What do we offer?
We offer a full time position in an international environment.
For further information, please call Laura Schollen 016 30 95 09