Research Protocol Analyst -IRB
This position is primarily in support of the Institutional Review Board (IRB). Responsible for protocol pre-review and coordination of protocol submissions of human subject research studies, including compliance with institutional, federal, and state policies and communicating with research investigators and their staff in an effort to facilitate protocol submission, review and approval processes.
Participates in Department effort to coordinate generation and distribution of meeting agendas, developing meeting summaries/minutes reflective of the committee’s protocol review activity, deliberations and determinations. Maintains audit-ready electronic files.
The position requires frequent interaction with Principal Investigators (PIs) and their administrative staff and the IRB membership. Helps coordinate activities through the electronic protocol submission system, Integrated Research Information System (IRIS), relative to the Human Research Subjects Protection area.
- Use iRIS to process varying protocol submission types (New Study, Amendments, Continuations, Deviations, Adverse Events) using the appropriate level of regulatory review in compliance with federal and state regulations. Processing of submissions entails a high level and detailed pre-review process in line with Department procedures and policies.
- Use iRIS to compose detailed and highly complex meeting summaries/minutes that describe the IRB deliberations, description of controverted issues and their resolution, justifications and ethical principles analyzed and reviewed by the Board.
- Use iRIS 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. Incorporate written comments provided by Board members into understandable, appropriate actions that must be addressed by the PI.
- Attend meetings with other COH committees (e.g., Rapid Improvement Event (RIE), etc.), as needed. Participate as an active member when attending these meetings, providing information/recommendations from the IRB’s perspective. Report back to the HRSP staff any issues requiring further discussion or problem solving.
- Assess PI responses to conditions imposed by the IRB 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 Operations Manager of any outstanding issues yet to be resolved or of the approvability of the response as it relates to the study protocol.
- Use iRIS 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 HRSP standards for timelines as determined by the Operations Manager/Director.
- Provide feedback 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 HRSP Operations Manager.
- Coordinate additional reviews and approval requirements needed from the Radiation Safety Committee (RSC), the Institutional Biosafety Committee (IBC), and the Occupational Safety and Biohazards Committee (OSBC), etc in order that the human subjects research project can be initiated.
- Take responsibility for prioritizing respective committee business and urgent requests submitted by PIs. Discuss prioritization issues with HRSP Operations Manager when necessary.
- Review submitted documents for completeness and accuracy.
- Maintain protocol documents as per the established HRSP requirements, in audit-ready fashion.
- Enter protocol actions in iRIS with accuracy and in a timely manner.
- Assure accurate entry and maintenance of data in IRIS in order to generate respective committee agendas, minutes, action notices, requests for continuation reports, and activity reports.
- Assist the HRSP Director and/or Operations Manager with completion of other assignments as necessary.
- Take leadership role in drafting and/or editing new and existing HRSP office procedures. Submit drafts for the HRSP Operations Manager 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.
- 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.
- Attend regional and/or national conferences to keep abreast of current issues and trends with regard to regulatory concerns and issues and represent COH in a professional manner.
- Attend meetings for and represent the HRSP Director and/or Operations Manager as necessary.
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 required. Bachelor’s degree in a science or medical field is preferred.
- 3-5 years experience in academic research setting required. Experience in managing studies in an academic research setting is preferred.
- Obtain certification as an IRB professional (CIP) within two years of hire, continue to maintain that certification through continuing education requirements or by taking the examination every 3 years. Current Certified IRB Professional (CIP) certification preferred.
- Supervisory experience preferred.
- Knowledge of federal and state of California regulations involving the use of human subjects 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.
- Ability to work with a high volume of protocols and submissions with competing deadlines.
- Knowledge of Microsoft Office; Access; NT for Windows, Microsoft Outlook .
- Excellent oral/written communication and organizational skills.
- Present a positive professional image.
- Demonstrate service orientation.
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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