Clinical Research Support Office/CRSO

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PositionKey Functions

 
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
     
     
     

 
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
     
     
     

 
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.
     
     
     

 
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

 
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)
     
     
     

 
Recruitment Outreach Assistant

     
  • Assists Recruitment Staff and CRO in executing strategies, answering calls, maintaining database.
     
     
     

 
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