IRB Operations Manager
Responsible for overseeing protocol review and the coordination of research subject protection activities among Research Protocol Analysts (RPA), including: maintaining compliance with institutional policies, communicating with research investigators and staff to facilitate protocol submission, review, and approval processes.
Manages the analyst team effort to coordinate the generation, distribution, and creation of IRB meeting agendas and monitor meeting minutes reflecting the committee’s protocol review activity and determinations.
The Manager is responsible for reviewing and critiquing Research Protocol Analyst (RPA) and Sr. RPA’s work product, conducting in-service educations sessions with RPAs, and ensures quality pre-review for research protocols. Ensures that RPAs and Sr. RPAs are correctly reviewing research protocols and monitoring their work and workload. Additionally, the Manager will advise staff of appropriate actions that should be taken in special circumstances.
Manages activities through the Integrated Research Information System (IRIS) relative to the Human Research Subjects Protection. Other duties include: manages and maintains audit-ready files and refers difficult or problematic issues to the Director.
- Leads in managing the routine work product of Research Protocol Analysts and Senior Research Protocol Analysts; mentors and enable their professional development and growth in the field of human subjects protection.
- Leads in developing standard operating procedures and policies and in their implementation operationally. Aids in the assessment and impact of new office policies and procedures on the overall work flow and the procedures required for appropriate implementation in relation to requirements that must be imposed upon investigators and their support staff in conjunction with the Director.
- Cooperates and works with other departmental managers to ensure effective interaction with other RPU departments. Advises PIs and their staff of the regulatory requirements and the specific Board/Committee requirements that must be fulfilled in order for a study to be conducted at COH.
- Reviews and provides feedback to RPAs regarding detailed and highly complex meeting minutes and summaries describing the Board deliberations on controverted issues and their resolution, medical justifications and ethical principles analyzed and reviewed by the Board, including citations of the applicable federal regulations where necessary. Reviews RPA’s analysis of IRB member’s reviews of submissions and ensures that appropriate actions are integrated into the minutes as action items addressed by the PI. Reviews the adequacy of the Research Protocol Analysts write-ups and their assessment of the protocols and associated consent forms for accuracy and consistency.
- Verifies and ensures the accuracy of RPAs detailed and highly complex correspondence, requiring a comprehensive level of knowledge of state and federal regulations and COH IRB policies and procedures, to PIs in order to assure that all concerns, rationales and technical questions of the Board are concisely communicated to PIs.
- Interacts with the PI and/or PI staff to advise them of the appropriateness of the response and communicates any requirements not addressed in order for the PI to secure IRB approval of the study. Following assessment advises the IRB Chair and/or OHRSP Director of any outstanding issues yet to be resolved or of the approvability of the response as it relates to the study protocol including the informed consent document(s).
- Maintains organized and accurate computer e-files, e.g., for the IRB, the currently approved version of the approved study consent form(s). Ensures the RPAs send to Clinical Trials on Line (CTOL) the approved password-protected PDF file(s) of the study consent form(s) and an electronic copy of the protocol for posting. The consents are downloaded by authorized users for purposes of consenting potential research subjects. Since these consents are considered legal documents, accuracy and attention to detail are very important.
- Ensures the RPAs review of study consent forms for compliance with regulatory requirements and against established consent requirements. At the direction of the IRB and using judgment, directly edits the consent form using established IRB policies, procedures and conventions, and as necessary directly discusses consent issues with the PI or his/her staff to negotiate and clarify the necessary changes. Discuss any problems or issues with the Director as needed.
- Develops and maintains daily operational procedures for the efficient processing of research proposals, including proper and effective receipt, logging, routine tracking, handling of protocol status inquiries, pre-review of submissions, issuing of action notices, and review of responses and related protocol business to the OHRSP
- In conjunction with the Director, reviews the IRIS system for effective receipt, logging, tracking, , pre-review of submissions, , and review of PI responses and related protocol business. Develops user interface questions and help text to facilitate creation and improvement of IRIS functions in regard to the submission, review, PI responses and tracking of research proposals and consent documents. Reviews IRIS and proposes changes, clarifications and improvements to the application.
- Places CTOL Alerts immediately following the IRB meeting or as directed by the OHRSP Director or IRB Chair in order to prevent enrollment of new subjects on a protocol due to safety issues, consent form updates or other issues which preclude new subject entry pending satisfactory resolution of the issue, including revision of the risks section of the informed consent document and/or creation of addendum consent forms for consenting subjects currently enrolled on study in regard to new information that may affect their decision to continue on a trial. Where appropriate, assists investigators in meeting conditions or criteria necessary to remove the Alerts.
- Coordinates reviews and approval requirements with the Clinical Trials Finance Office for clinical trials agreements, the Radiation Safety Committee (RSC), the COH Scientific review bodies (CPRMC and PRMC), and the Institutional Biosafety Committee (IBC) (for gene transfer studies), making sure that these additional department/committee approvals have been secured prior to release of the clinical trial for research subject accrual.
- Takes leadership responsibility for prioritizing IRB business and urgent requests submitted by PIs Discusses prioritization issues with Director when necessary.
- Reviews submitted documents for completeness and accuracy.
- Receives, evaluates and responds to requests for emergency use of investigational drugs, devices and biologics.
- Assembles protocol files as per the established OHRSP requirements, in audit-ready fashion.
- Prior to an external audit, locates the appropriate protocol file(s); determines adequacy for the audit; is present during the audit to answer any questions and to assist the auditor in clarifying issues, locating correspondence and other protocol-related documents that may not be easily located or apparent at time of the audit. Represents the IRB office in a professional and appropriate manner during these external reviews of IRB protocol files.
- Monitors timeliness of P.I. responses, following up with PIs and involving the OHRSP Director when necessary.
- Assists the Director with completion of other assignments as necessary.
- Applies knowledge of federal and state regulations, policies and guidelines to review and analyze protocol submissions. Determines the appropriate review mechanism to be employed (i.e., expedited, full committee, emergency reviews) and directly advises the PI and/or PI staff. Discusses with OHRSP Director as necessary.
- Takes leadership role in drafting and/or editing new and existing IRB office procedures. Submits drafts for the Director and other IRB RPAs to critique and edit. Takes responsibility for finalizing document, conducts an in-service to familiarize RPA and other IRB office staff of the procedures, and places the e-documents in the established electronic folder for future use and access as needed.
- Assists with OHRSP intranet maintenance:
- Assists in creating and maintaining electronic policy documents
- Tests files for adequacy.
- Participates in lean six sigma activities on a regular basis.
- Conduct in-service training for clinical research associates, departmental secretaries, protocol coordinators and protocol nurses on OHRSP requirements, review mechanisms and Board functions, website location of related forms 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 representing COH in a professional manner.
- Manages Research Protocol Analysts and Senior Research Protocol Analysts including annual performance evaluations.
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. Bachelor’s degree in a science or medical field is preferred. Seven or more years IRB or other research regulatory experience in academic research setting.
- Certified IRB Professional upon hire or within three years of employment is preferred.
- 4 or more years of supervisory experience preferred.
- Lean, six sigma process improvement preferred.
- Experience in managing clinical trials in academic research setting preferred.
- Excellent oral/written communication and organizational skills.
- Present a positive professional image; demonstrating service orientation.
- Knowledge of complex federal and state regulations involving the use of human subjects in research.
- Analytical skills to review research protocols and ability to edit consent forms against established criteria in conformance with state and federal regulations.
- Effective interpersonal skills to directly communicate complex information with PIs and administrative and research personnel.
- Strong writing skills to document and summarize salient points and results of meeting proceedings. Ability to directly communicate the same verbally to PIs.
- Ability to work as a team member in an office where there are numerous deadlines and time-sensitive issues requiring judgment and flexibility.
- Working knowledge of relational databases for management of research protocols and study consents.
- Ability to pay attention to details involving protocols and consent documents.
- Experience in research environment or as a Clinical Research Associate.
- Knowledge of Microsoft Office; Word; Excel; Access; NT for Windows.
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. #LI-LF
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