Clinical Research Officer |
- 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
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Clinical Research Specialist (2) |
- 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
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IND Specialist/Monitor |
- Education of investigators as regards requirements for Investigational New Drug Applications (INDs), and roles of IND-Sponsors and Investigators
- Direct assistance to investigator-sponsors in preparation and submission of IND related materials, as requested
- Creation of a database to track IND milestones, generate reminders to aid in compliance
- Creation and support of web-based resources and guidance for investigators and Sponsor-Investigators of INDs
- Creation of written guidelines for Investigator-Sponsor monitoring of IND studies
- Assistance to Investigators in implementation of monitoring, as requested
- Other non-IND protocol monitoring activities
- Creation of powerpoint presentations, workshops, etc. for educational purposes
- Develops and applies quality assurance practices for domains of work, in collaboration with CRO.
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Associate Auditor/Monitor |
- Lead Monitor for CRSO for non-IND protocols
- Coordinates (with CRO) monitoring schedule, priority, and delegation of monitoring duties.
- Recommends Monitoring SOPs in collaboration with CRO and IND specialist
- Recommends updates to monitoring SOPs
- Responsible to ensure consistent application of SOPs across departmental monitoring
- Development and application of quality assurance practices for monitoring program, in collaboration with CRO
- Develops templates and tools to improve workflow
- Integrates tools into electronic clinical research system in collaboration with CRO and IT as appropriate
- Develops educational presentations for Clinical Coordinators and other research staff to communicate standards, and incorporate feedback
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Recruitment Outreach Staff |
- 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)
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Recruitment Outreach Assistant |
- Assists Recruitment Staff and CRO in executing strategies, answering calls, maintaining database.
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Secretary |
- Provides clerical support to CRO and CRSO staff
- Filing and general office work, including maintaining supplies, managing mail, answering phones, messaging;
- Coordination of scheduling CRSO meetings for staff and with non-CRSO requests
- Intake of requests to the CRSO for training, monitoring, orientation, etc.
- Follows SOPs for triage of calls, requests
- Keeps accurate log of CRSO activities
- Helps to maintain QA data for CRSO
- Assists in converting text to powerpoint presentations using recommended styles, assist
- Assists in tracking budget for CRSO
- Takes and keeps minutes for CRSO meetings
- Arranges for travel, lodging, for invited guests according to RU guidelines
- Schedules event rooms, refreshments for s at request of CRO
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