Oversight and coordination of all CRSO staff and function
Coordination of policy activities of across departments as regards education, training and oversight in appropriate aspects of protocol design, implementation and conduct.
Human subject protections and ethics, training and implementation
Education and policies to ensure GCP
Oversight and education in compliance in research conduct, including Monitoring and Audit activities
Research subject advocacy
Patient Recruitment and Center outreach
Liaison with IRB
Leadership in Regulatory knowledge and support through participation in governance and education
Participation in national consortia as appropriate
Fluent in all functions of research implementation and conduct
Educates the research community in research conduct and GCP, CRSO functions, services, and resources, use of interpreters, etc.
Assists in creation of on-line Investigator's Guide and guidance for protocol conduct, and written monitoring standards, FAQs
Provides guidance to research teams in planning protocol implementation workflow, CRFs, and other tools
Creates new templates and tools, as appropriate for general use by research teams
Provides direct assistance to investigators in protocol development and in creation of Data And Safety Management Plans
Assists CRO in DSMP review and recommendations
Recommends improvements to workflow for electronic clinical research system
Serves aspects of research subject advocacy, monitoring informed consent interactions, investigating subject complaints, conducting human subject protection investigations
Assists research staff in navigating requirements for special circumstances, e.g. minors, subjects with diminished capacity, foreign language subjects, and facilitates access to services
Helps to develop and maintain CRSO website
Enhancing the Informed Consent process through oversight of interactions and development of innovative program (Plain language program, TEACH BACK) to improve communication and comprehension.
One Clinical research Specialist will help to promote the TEACH BACK method with research staff, coordinators and investigators for improving informed consent comprehension
One Clinical research Specialist will help the CRO to develop a Plain Language initiative at RU including an ICF editing role, workshops and other forms of education.
One Clinical research Specialist will help the CRO manage the Picker Clinical Research Participant Perception of Care survey development project in collaboration with participating CTSAs and GCRCs.
Develops and applies quality assurance practices for domains of work, in collaboration with CRO
Responsible in collaboration with CRO for overall recruitment\ for RUH
Develops outreach initiatives to other institutions and community based
Maintains RUH external website listing currently active protocols, resources for volunteers organizations to educate the public about RUH research programs and recruit participants
Staffs 1-800-RUCARES central recruitment line and triages potential volunteers to appropriate study staff
Coordinates advertising and recruitment strategies with individual research teams
Liaises with commercial advertisers, negotiates favorable rates, places advertisements, arranges for CRSO/investigator cost sharing to support recruitment
Maintains Recruitment database incorporating CRSO and investigator recruitment information for quality assurance purposes.
Identifies opportunities for investigators to speak to potential collaborators, or potential participant populations and facilitates such events
Refers potential collaborations appropriately
Assists in developing interactive data-base for potential volunteers to automate information delivery and simplify early triage (in collaboration with CRO) and IT)
