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Institutional Review Board Manager

Company: Riverside University Health System
Location: Moreno Valley
Posted on: September 6, 2019

Job Description:

ABOUT THE COUNTY OF RIVERSIDERiverside County offers diversity that few locations can match. To find out more, please visit http://www.countyofriverside.us.ABOUT THE DEPARTMENTRiverside University Health System (RUHS) is an integrated health system delivering exceptional care to residents of Riverside County, through a network of skilled healthcare professionals. RUHS includes the 439-bed Medical Center in Moreno Valley accredited by the Joint Commission, 10 Federally Qualified Health Centers (FQHCs), specialty clinics, and the departments of Behavioral and Public Health. RUHS is a teaching organization that provides training for doctors, nurses and allied health professionals, and is affiliated with Loma Linda University, University of California System and Western University of Health Sciences. RUHS employs about 6,000 team members.The RUHS-Medical Center is a Level II Trauma Center and provides high quality adult and pediatric acute care, emergency and trauma medical care, and specialized health services that include the Stroke Center and chronic disease management. The FQHCs, located throughout Riverside County, deliver comprehensive outpatient primary and preventive care. Community-based services for adults and children with mental health issues and substance abuse challenges are provided by the RUHS-Behavioral Health Department. The RUHS-Public Health Department offers a wide range of services and programs, such as disease control, children's medical services and nutrition services, to promote and protect the health of the residents of Riverside County.The RUHS is committed to the health and well-being of all communities in Riverside County.JOB DESCRIPTIONThe Institutional Review Board -Manager (IRB- Manager) applies and implements federal regulations, Institutional Review Board (IRB) guidelines, and institutional policies related to the protection of human research subjects and research integrity to ensure conformance with ethical and regulatory standards. The position serves as an expert resource to Riverside University Health Systems research community (physicians, staff, residents, students, etc.) and as the liaison between the research community and other IRBs to ensure that research conducted by RUHS and affiliate investigators and research staff meet all regulatory and institutional policies and procedures to protect human subjects participating in RUHS research. The IRB-Manager manages and coordinates the RUHS-MC Institutional Review Board and Human Research Protection Programs.EXAMPLES OF ESSENTIAL DUTIES1. Provide consultation and education to faculty, staff, students, and affiliate investigators and research staff on the application and implementation of the federal regulations, state laws, and institutional policies for RUHS human subjects research. 2. Perform preliminary administrative review of complex research protocols for consistency and completeness of materials and identifies problems and issues with submissions. Review Informed Consent Documents (ICDs) for protocol and amendmentspecific content and to ensure presence of federally mandated elements of informed consent. Review IRB application submissions for completeness and assign reviewers to the studies. Evaluate reports of unanticipated problems, amendments and continuing review forms, and prepare recommendations to the committee.3. Schedule and make arrangements for all IRB Meetings. Arrange and coordinate all aspects of the committee meeting materials and distribute 7-10 business days prior to IRB meeting.4. Convey all decisions and/or IRB actions in writing to investigators in a clear, concise manner. Create and maintain institutional records in the form of meeting minutes that summarize the discussions and deliberations of the IRB. Create and maintain the official institutional records, both in an electronic format (computerized data management system) and in physical copies (IRB protocol files), to reflect the actions and decisions of the IRB. Issues outcome letters based on conditions imposed by the committee. 5. Identify and track approved research protocols, including implementation of office-established procedures to assist investigators in complying with conditions imposed by the IRB. 6. Serve as a liaison between the Institutional Review Board, the principal investigators, study coordinators, human subjects, and affiliate institutions, providing consultation and guidance to facilitate the ethical and regulatory conduct of human subject research. 7. Develop standard operating procedures for the IRB and Human Research Protection Program that adhere to federal and state regulations governing research on human subjects. 8. Assist in the development of Institutional documents utilized by RUHS investigators. 9. Collaborate with the Office of Compliance by performing research compliance audits of approved IRB research studies. Report serious noncompliance issues to the IRB Chair, Research Institutional Officer, Research Executive, and Compliance Officer.RECRUITING GUIDELINES1. Education: Bachelor's degree; Four years of progressively responsible work in regulatory experience or IRB Management may substitute for the Bachelor degree.2. Certification: Certification as an IRB professional (CIP) or within 12 months of hire.3. Experience: Minimum two years performance improvement and/or regulatory experience; IRB experience preferred. Computerized data management software IRB.net experience highly desired. High level of organizational skills, specifically related to document control, also includes written and verbal communication, creative problem solving and commitment to organizational goals. Must have knowledge of, and experience in, the interpretation of Federal and State regulations particularly regarding the protection of human subjects in biomedical research (to include working knowledge of Federal regulations for human research: 21 CFR parts 50, 56, and 45 CRF 46).VETERAN PREFERENCE REQUESTIf you are a veteran, a spouse of a 100% disabled veteran, or a surviving spouse of a veteran who died of service-connected causes, submit a copy of your (or your spouse's) Member-4 Form DD-214 (or NGB-22) indicating dates of service, and a copy of your spouse's letter of disability (if applicable) to the Human Resources Department at recruiting@rivco.org. For privacy reasons, it is recommended that you remove your social security information from the document(s). A Human Resources Representative will review the materials and determine if you qualify for veterans' preference.All documentation referenced above should be submitted to recruiting@rivco.org before this job posting expires. Please remember that you will need to resubmit your Member-4 Form DD-214 (or NGB-22), and a copy of your letter of disability (if applicable) for some public safety positions even if you have submitted one in the past to the County of Riverside.WHO MAY APPLYThis recruitment is open to all applicants.Applicants who are current County of Riverside employees and/or current employees of the Department/Agency may be considered before other applicants depending on the volume of applications received.Qualified applicants may be considered for future vacancies throughout the County.APPLICATION PERIODThe preliminary closing date for this posting is August 19, 2019, at 11:59 pm however postings may close at any time. If this posting is active past August 19, 2019, it may close at any time.Applications received prior to the closing date will be considered based on the information submitted. Changes or alterations cannot be accepted. No late applications will be permitted.Applications must be submitted through Job Gateway at http://www.rc-hr.com/Careers/JobGateway.aspxInclude relevant work experience details on resume and/or application. Applicants who fail to provide information demonstrating they possess the position requirements may not be considered further in the application process. A description of job duties directly copied from the job classification or job posting will not be considered.Upload a copy of any license(s), degrees, and/or related employment documents to your Job Gateway account. BASED ON THE NUMBER OF APPLICATIONS RECEIVED, THIS POSTING MAY CLOSE WITHOUT NOTICE.CONTACT INFORMATIONIf you have questions regarding this posting, please contact Jeremy Holforty at jholfort@rivco.org.GENERAL INFORMATIONFor specific questions regarding this position, contact the recruiter listed.Benefits and detailed job description information is available for all Riverside County classifications on the job descriptions page at http://rc-hr.com/Careers/JobDescriptions.aspx.Information regarding employment requirements, including pre-employment drug/alcohol test, background check, physical exam, initial probationary period is available at www.rc-hr.com. Procedures for reasonable accommodation, as required by the Americans with Disabilities Act (ADA) and Fair Employment and Housing Act (FEHA), may be found at http://dao.rc-hr.com.-Applications must be submitted through the Riverside County Job Gateway System. -Current County Employees must use their Employee Self-Service Account to apply. -All other applicants must apply using https://jobs.co.riverside.ca.usThe County of Riverside is an Equal Opportunity Employer. It is the policy of the County of Riverside to provide employment opportunity for all qualified persons. All applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender, gender identity, gender expression, marital status, ancestry, medical condition (cancer and genetic characteristics), genetic information, or denial of medical and family care leave, or any other non job-related factor.

Keywords: Riverside University Health System, Moreno Valley , Institutional Review Board Manager, Executive , Moreno Valley, California

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