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Clinical Research Support Office/CRSO

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Position Key Functions

Clinical Research Officer

  • Oversight and coordination of all CRSO staff and functions
  • Coordination across departments of policies and activities concerning education, training, and post-approval oversight as they relate to protocol design, implementation and conduct.
  • Harmonization of Human subject protections and ethics, training and implementation
  • Harmonization of education and policies to ensure GCP
  • Oversight and education in compliance in research conduct, including Monitoring and Audit activities
  • Research subject advocacy
  • Clinical Research Recruitment and Outreach Support Service (CRROSS) core function
  • Community Engagement Research Core Co-Director
  • Vice-Chair, Institutional Review Board
  • Leadership in regulatory knowledge and support through participation in governance and education
  • Participation in national consortia as appropriate
  • Scholarly work including development and dissemination of innovative tools and measures

Clinical Research Specialist

  • Fluent and broadly experienced in all regulatory aspects of research implementation and conduct
  • Educates the research community in research conduct and documentation complementary with activities of the Clinical Translational Research Facilitation Office.
  • Helps to maintain and update on-line Investigator's Manual, and written standards regarding research conduct and oversight
  • Conducts audits (early, not-for-cause, and for-cause) according to written SOPs
  • Maintains a database to track audit findings; identifies trends and pattern within or across studies and develops training, tools and policy recommendations to enhance compliance
  • Manages institutional clinical trails registration account and tracks protocol compliance
  • Provides training to investigators regarding their responsibilities for trial registration assistance and provides assistance in registering clinical trials and uploading required results and documents
  • Assists in development of new templates and tools, as appropriate for general use by research teams
  • Education of investigators in the requirements for Investigational New Drug Applications (INDs), for Investigational Device Exemptions (IDE), and regarding the responsibilities of the Investigator-Sponsor
  • Maintains the Program of IND Assistance web page
  • Provides guidance to Investigator-sponsors in preparation and submission of IND related materials, as requested
  • Creation of powerpoint presentations, workshops, etc. for educational purposes
  • Manages the electronic GCP Newsletter
  • Develops and applies quality assurance practices for domains of work, in collaboration with CRO

Recruitment Specialist

  • Responsible in collaboration with CRO for overall recruitment for RUH
  • Leads recruitment staff in comprehensive recruitment consultations provided during Protocol Navigation
  • Drafts Recruitment Plans, advertising strategies, and ad copy
  • Implements advertising and recruitment strategies with individual research teams
  • Liaises with commercial advertisers to negotiate favorable rates; arranges for CRSO/investigator cost sharing to support recruitment
  • Develops outreach initiatives to other institutions in collaboration with Community Engagement Specialist
  • Maintains RUH external website listing currently active protocols to educate the public about RUH and recruit participants
  • Staffs 1-800-RUCARES central recruitment line, prescreens and refers potential volunteers to appropriate study staff
  • Manages the IRB-approved Research Volunteer Repository; tracks metrics and outcomes
  • Helps with regulatory filings related to IRB-approved protocol for Research Volunteer Repository 
  • Maintains the Recruitment database incorporating CRSO and investigator recruitment information for quality assurance purposes.

Recruitment Assistant
  • Assists Recruitment Specialist in recruitment consultation, and design and execution recruitment strategies, 
  • Staffs the call center; prescreens and refers research volunteers to study staff, and/or directly schedules screening visits
  • Follows SOPs for triage of calls, requests
  • Administers data transfer between the CRSO and the vendor deploying the Research Participant Perception Survey (RPPS) 
  • Helps with regulatory filings related to IRB-approved protocols for conducting RPPS surveys
  • Coordinates with Community Engagement staff to organize outreach events 
  • Assists in tracking grants and operational budgets for CRSO
  • Manages and documents CRSO Staff Meetings
  • Provides clerical support to CRO and CRSO staff, including purchasing and budget reconciliation
  • Helps to maintain QA data for CRSO across core functions
  • Filing and general office work, including maintaining supplies, managing mail, answering phones, messaging
  • Arranges for travel, lodging, for CRSO staff and invited guests according to RU guidelines
  • Schedules event rooms, refreshments at request of CRO
Site Map Investigators Log-inPositionKey Functions Clinical Research Officer Oversight and coordination of all CRSO staff and functionsCoordination across departm