For one of our clients, we are looking for a Nurse to work as a Study Execution Coordinator.
- Do you have a Nursing degree?
- Do you have a first experience within the field of Clinical Trials?
- Are you fluent in French and in English?
Then you might be the candidate we are looking for.
As Study Execution Coordinator, you have several responsibilities.
- You are 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 between the Study Teams and the Clinical Research Unit.
- You participate in study coordination activities of the Clinical Research Unit: 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...
- You 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 the Head of Study Coordination.
- You work with the CRU study team for the management of the day to day activities of the studies, including immediate & long term problem solving, communication and protocol adherence
- You support Principal Investigator, Project Manager and clinical department in the unit
- You ensure close follow up on clinical activities for assigned protocols
- You contribute to the development of study conduct tools and providing expertise with respect to specific protocol assessments
- You review and provide input on protocols; interpreting protocol details and organizing study activities including the creation of study documents
- You develop and provide technical capabilities and competencies necessary for clinical conduct of studies in the CRU (e.g., drug administration, clinical/physiological measurements, sample collection/processing, basic nursing care, emergency care)
- You perform ongoing & regular quality reviews of the data for achieving audit-readiness and meeting deadlines
- You perform informed consent sessions in both languages (Fr & English) and administering informational tools to assist volunteers with study comprehension and compliance
- You solve queries specific to subject data collection
- You oversee the collection and documentation of electronic and/or written study data;
- You participate in QC of study set up in the electronic data capture system for protocols according to protocol requirements, CRU SOP’s, and standardized processes, as appropriate collaboration with the PI to include subjects for eligibility using protocol inclusion/exclusion criteria
- You assist in study design for feasibility, implementation, and reporting of clinical trials
- You have a Nursing degree and a first experience within the field of Clinical Trials.
- You are fluent in French and in English
- You have a synthetic mindset and you are able to give training
- You have strong communication and presentation skills
- You are stress resistant, accurate and rigorous