Research Protocol Analyst - LRSP

Position Summary:

This position is primarily in support of the Institutional Research Oversight Committees. Responsible for administrative protocol review and coordination of laboratory research subjects protection activities, including compliance with institutional policies and communication with research investigators and their staff in an effort to facilitate protocol submission, review and approval processes. Participates in team effort to coordinate generation and distribution of meeting agendas and develops meeting summaries/minutes reflective of the committee’s protocol review activity, deliberations and decision-making. Maintains audit-ready paper and electronic files. The position requires frequent interaction with Principal Investigators (PIs) and their administrative staff. Responsible for accurate database input and upkeep. Helps coordinate activities through the Integrated Research Information System (IRIS) relative to the Laboratory Research Subjects Protection area. Advises all research staff regarding compliance with federal, state, local and institutional policies as they pertain to animal care and use and the use of other research materials.

Essential Functions:

  • Use iRIS (electronic protocol submission system) to compose detailed and highly complex meeting summaries/minutes that describe, in detail, the various committee deliberations, description of controverted issues and their resolution, justifications and ethical principles analyzed and reviewed by the committees.
  • Use iRIS system to compose detailed and highly complex correspondence, requiring a comprehensive level of knowledge of state and federal regulations and COH policies and procedures, to PIs to assure that all concerns, rationales and technical questions of the respective committees are concisely and intelligibly communicated to PIs. This correspondence is sent via email and through iRIS.
  • Attend meetings of the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), the Occupational Safety and Biohazards Committee (OSBC) and the Stem Cell Research Oversight Committee (SCRO to gain a perspective of committee functions and participate when needed by providing information/recommendations.
  • Assess PI responses to conditions imposed by the Oversight Committees for completeness and appropriateness. Interact with PI and/or PI staff directly to advise them of the appropriateness of the response and communicate any requirements not addressed in order for the PI to secure approval of the study protocol. Following assessment, advise the respective Chair and/or the LRSP Director of any outstanding issues yet to be resolved or of the approvability of the response as it relates to the study protocol..
  • Use iRIS and other systems to maintain organized and accurate computer e-files for each respective protocol component, e.g., protocol, title page, consent documents.
  • Develop and maintain daily operational procedures for the efficient processing of research proposals and responses to conditions, including routine tracking of protocol workload, handling of protocol status inquiries, issuing of action notices, and review of responses and related protocol business while maintaining LRSP standards for timelines.
  • Participate in meetings with the iRIS senior systems analyst regarding electronic processing of research proposals, including proper and effective receipt, logging, routine tracking, handling of protocol status inquiries, generation of meeting agendas and meeting minutes, issuing of action notices, and review of responses and related protocol business. Develop user interface questions and help text to facilitate creation and improvement of iRIS functions in regard to the submission, review, and tracking of research proposals. Review iRIS and propose changes, clarifications and improvements to the application.
  • Use iRIS to monitor protocol approval dates, generate protocol status reports, and inform PIs of impending protocol lapses through electronic reminder notices. Discuss any problematic issues with the LRSP Director.
  • Coordinate additional reviews and approval requirements needed from other standing COH committees.
  • Take leadership responsibility for prioritizing respective committee business and urgent requests submitted by PIs. Discuss prioritization issues with LRSP Director when necessary.
  • Review submitted documents for completeness and accuracy
  • Assemble protocol files as per the established LRSP requirements, in audit-ready fashion.
  • Maintain membership rosters for the research oversight committees. Recruit and confirm internal and external reviewers for protocols committee review
  • Enter protocol actions in iRIS and other systems with accuracy and in a timely manner.
  • Assure accurate entry and maintenance of data in IRIS and other systems in order to generate respective committee agendas, minutes, action notices, requests for continuation reports, and activity reports.
  • Assist the LRSP Director with completion of other assignments as necessary.
  • Take leadership role in drafting and/or editing new and existing LRSP office procedures. Submit drafts for the LRSP Director and other Research Protocol Analysts (RPAs) to critique and edit. Take responsibility for finalizing document, conduct an in-service to familiarize RPAs and other office staff of the procedures, and place the e-documents in the established electronic folder for future use and access as needed.
  • Website maintenance: assist in creating and updating guidance documents, policies and procedures, coordinate posting of files as they are created or are amended
  • Perform quality control activities as required.
  • Conduct in-service training for PIs and their staff on respective committee requirements, review mechanisms and Board functions, website location of related forms and templates and their appropriate uses, etc.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

Minimum Education and Skills Required for Consideration:

  • Bachelor’s degree and 3-5 years experience in academic research setting. Bachelor’s degree in a science or medical field is preferred.
  • Certified Professional in IACUC Administration (CPIA) is preferred.
  • Knowledge of federal and state of California regulations involving the use of animals and other materials in research.
  • Analytical skills to review research protocols in conformance with respective committee requirements and requests.
  • Effective interpersonal skills to directly communicate complex information to PIs and their administrative and research personnel.
  • Strong writing skills to document and summarize salient points and results of respective committee meeting proceedings. Ability to directly communicate the same in action notices to PIs.
  • Ability to work as a team member in an office where there are numerous deadlines and time-sensitive issues requiring judgement and flexibility.
  • Working knowledge of relational databases for management of research protocols.
  • Ability to pay attention to details involving research protocols and related documents.
  • Experience in research environment.
  • Ability to display tact/consideration in dealing with COH employees.
  • Knowledge of Microsoft Office; Access; Microsoft Outlook.

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy. Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

City of Hope is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

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