University Hospitals ir veselības aprūpes organizācija, kas nodrošina primāro aprūpi, specializēto aprūpi, neatliekamo aprūpi un citus medicīniskos pakalpojumus. Tās darbā uz pacientu vērsta ārstēšana tiek apvienota ar medicīnisko izglītību un pētniecību, pulcējot klīniskās komandas, izglītotājus un pētniekus, kuri koncentrējas uz veselības aprūpes rezultātu uzlabošanu. University Hospitals piedāvā karjeras iespējas veselības aprūpes nodrošināšanas, medicīnisko pakalpojumu, izglītības, pētniecības un lielas aprūpes organizācijas darbību atbalstošo operatīvo funkciju jomās.
IRB Specialist I, Clinical Research at University Hospitals
Review human-subject research protocols and coordinate IRB meetings. Support investigators and clinical research operations at the Center for Clinical Research in Cleveland.
Apraksts
- Stay current on federal, state, and local laws, regulations, and guidance for human-subject research.
- Review human research protocol submissions for compliance with IRB policies, institutional procedures, applicable regulations, and ethical principles.
- Coordinate IRB meetings and prepare agendas and materials.
- Document medical and ethical issues discussed to accurately record IRB determinations.
- Liaise with IRB committees, investigators and their designees, and Center for Clinical Research and Technology staff.
- Contribute to special projects.
- Carry out other assigned duties.
- Follow organizational policies and standards.
- Protect and securely maintain Protected Health Information (PHI).
Prasības
- Bachelor’s degree in health sciences, bioethics, or a related field is required.
- At least one year of experience in research, research administration, regulatory affairs, clinical research, or laboratory research is required.
- IRB experience is preferred.
- Knowledge of medical concepts and terminology.
- Accurate typing skills.
- Ability to communicate information in grammatically correct written form.
- Strong organizational skills and attention to detail.
- Ability to work independently and as part of a team while meeting deadlines.
- Good attendance record.
- Service-oriented, self-motivated, professional, discreet, and able to act with integrity.
- Knowledge of research regulations is preferred.
- Understanding of current NIH, DHHS, OHRP, and FDA guidance on human-subject research.
- Ability to handle multiple duties at once and manage occasional increases in workload.
- Ability to prioritize and process IRB submissions efficiently.
- Proficiency with PCs and Microsoft Office software.
- Human Subjects Protection (CITI) certification must be obtained within 30 days.
- Research certification is preferred.
- Ability to protect and securely maintain Protected Health Information (PHI).
Priekšrocības
- Regular full-time employment.
- Hybrid work arrangement.
- Day shift.
- Annual training.
- 10% travel.