Société : Oxford Global Resources Lieu : Machelen Flanders Site source : Talent BE
Ensures compliance to the study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Client Standard Operating Procedures.
Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes.
Primary focus is on providing support of site management activities.
ResponsibilitiesEnsure regulatory and clinical protocol compliance for all assigned clinical projects.Review informed consent document to ensure all required elements are included.Provide product/protocol specific support and training to internal and external clinical personnel.In partnership with assigned field staff and in-house personnel; coordinate the start-up and maintenance of the clinical study site.Coordinate and lead activities with study specific committees, vendor services, and core labs.Conduct the follow-up and resolution of findings from monitoring visits and audits.Independently review site compliance and raise issues to study management.Serve as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate.Communicate and collaborate with all levels of employees, customers, contractors, and vendors.Apply general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.Contribute to global process improvements and provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs).Identify and routinely use the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.RequirementsUniversity degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineeringInternship or first working experience in clinical research.Fluent in EnglishMust have strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills.Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.Proficiency in Microsoft Office Suite and relevant clinical applications.Ability to work independently when necessary.Capable of exchanging straightforward information, ask questions, and check for understanding.Existing right to work in Europe is requiredBenefitsFulltime positionOffice-based at client's location (Min.
4 days/week in the office)A balanced salary package based on your capabilities and experience, including extra legal benefitsVacancy number:
