The Rockefeller University Hospital

Clinical Research Support Office/CRSO

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

Clinical Research Support Office/CRSO