DescriptionThe 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.
What we are looking for
Implement the quality management system for human subject research, with special focus on clinical trials.
- Develop Standard Operational Procedures (SOPs) (including linked guidelines, forms and templates) or coordinate with other teams in charge of developing SOPs
- Maintain the SOP inventory
- Coordinate the review process of SOPs
- Organize and track internal training on SOPs
- Maintain an internal registry of clinical trials conducted by ISGlobal researchers and ensure that trials are conducted according to regulatory requirements
- Ensure that clinical trials are registered at public databases (clinicaltrials.gov or similar) and the information is updated when applicable. Support researchers in clinical trials registration
- Support 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 team
- Support the Human Resources team to identify specific training needs on clinical trials management
- Verify that ISGlobal responsibilities are covered in case of studies sponsored by ISGlobal
- Monitor proper archiving of projects in collaboration with the project managers
- Coordinate the internal audit process with the external consultants
- Prepare information for reporting the activity on clinical trials (SIRECS, External Advisory Board, etc.)
- Contribute to quality management sections in research proposals and protocols
- Support researchers and project managers on quality management / quality assurance issues during the implementation of the clinical trials
- Organizing periodic meetings with projects managers and researchers for general project review from a quality assurance perspective
Training and experience
- Degree in health sciences
- Master or PhD on Clinical Research or Master in Clinical Trials Monitoring or equivalent experience will be an asset
- Minimum of 5 years of experience in managing clinical trials
- Knowledge of regulatory agencies (AEMPS, EMEA, FDA) and ethics committee submissions
- Experience on quality management
- Accreditation on Good Clinical Practices and the regulations necessary to protect human subjects and the conduct of clinical research
- Experience in low and middle income countries will be an asset
- Audit experience will be a plus
- Proven experience in a communication role, both oral and written.
- Understanding of the role of research and development in clinical trials.
- Outstanding writing and communication skills in English and Spanish.
- Ability to work effectively independently.
- Demonstrable adaptability and openness to change.
- Experience in fostering integration and teamwork.
- Problem resolution.
- Attention to detail.
- Ability to work under pressure.
- Full 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 apply
Applicants must fill in the request form and include the following code reference position: Quali_Manag_Coord_Nov22, attach the CV and a Cover Letter. Each attached document must be named with the candidate name and surname.
The receipt of applications will be open until 30/11/2022.
Applications will be accepted until 17.00 CET of the closing date.
Only the applications submitted through the request form will be considered.
Only shortlisted candidates will be contacted.
The interviews could be placed during the reception candidatures period.
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.
ISGlobal supports the initiative #ScienceforUkraine. Therefore, to sustain Ukraine’s presence in the European Research Area and international scholarly community, candidates from Ukraine on all levels of scholarly career are welcome: students, PhD candidates, early career researchers and senior scholars.
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.