Descripción: The Barcelona Institute for Global Health, ISGlobal, is the fruit of an innovative alliance between academic, government, and philanthropic institutions to contribute to the efforts undertaken by the international community to address the challenges in global health. ISGlobal provides a hub of excellence dedicated to scientific research and the provision of health care. The institute, which originated in a joint initiative of the Hospital Clínic de Barcelona and the University of Barcelona, has amassed over 30 years of experience in the field of global health. The pivotal mechanism of its work model is the transfer of knowledge generated by scientific research to practice, a task undertaken by the Research, Training and Policy and Global Development departments. Its ultimate goal is to help close the gaps in health disparities between and within different regions of the world.
Lugar: Barcelona
What we are looking for:
Key ResponsibilitySpecific Duties: Develop Standard Operational Procedures (SOPs) (including linked guidelines, forms and templates) or coordinate with other teams in charge of developing SOPsMaintain the SOP inventoryCoordinate the review process of SOPsOrganize and track internal training on SOPsMaintain an internal registry of clinical trials conducted by ISGlobal researchers and ensure that trials are conducted according to regulatory requirementsEnsure that clinical trials are registered at public databases (clinicaltrials.Gov or similar) and the information is updated when applicable. Support researchers in clinical trials registrationSupport researchers to track annual re-approvals from ethics committees (mainly for US funded studies and studies outside Spain)Ensure that all personnel involved in clinical trials are properly trained in Good Clinical Practice, in collaboration with the Human Resources teamSupport the Human Resources team to identify specific training needs on clinical trials managementVerify that ISGlobal responsibilities are covered in case of studies sponsored by ISGlobalMonitor proper archiving of projects in collaboration with the project managersCoordinate the internal audit process with the external consultantsPrepare information for reporting the activity on clinical trials (SIRECS, External Advisory Board, etc.)Contribute to quality management sections in research proposals and protocolsSupport researchers and project managers on quality management / quality assurance issues during the implementation of the clinical trialsOrganizing periodic meetings with projects managers and researchers for general project review from a quality assurance perspective Training and experienceDegree in health sciencesMaster or PhD on Clinical Research or Master in Clinical Trials Monitoring or equivalent experience will be an assetMinimum of 5 years of experience in managing clinical trialsKnowledge of regulatory agencies (AEMPS, EMEA, FDA) and ethics committee submissionsExperience on quality managementExperience in low and middle income countries will be an assetAudit experience will be a plus SkillsProven experience in a communication role, both oral and writtenUnderstanding of the role of research and development in clinical trialsOutstanding writing and communication skills in English and SpanishAbility to work effectively independentlyDemonstrable adaptability and openness to changeExperience in fostering integration and teamworkProblem resolutionAttention to detailAbility to work under pressure Language levelFull time contract (40 hours/week), flexible
Compensation for this position will be based on the applicant's experience and qualifications according to internal salary scales (40-45M annual gross salary)
Starting date: Immediate
How to applyApplications will be accepted until 17.00 CET of the closing date.
In ISGlobal we are committed to maintaining and developing a work environment in which the values and principles of our organization are respected and equal opportunities between women and men be promoted in each of the areas in which we operate, not tolerating discrimination based on criteria such as age, gender, marital status, race, ethnicity, functional diversity, political leanings, religion, sexual orientation, gender identity or gender expression. We confirm our commitment towards the value of the diversity of our staff and student population and seek to promote peace, equity, diversity and inclusion as essential elements in contribution to improving health worldwide.
#J-18808-Ljbffr