Research Specialist II (IRB Specialist) - Human Research Protection Program (Finance)

The County of Riverside's Riverside University Health System (RUHS) and its Institutional Review Board (IRB) and Human Research Protection Program seek a Research Specialist II (IRB Specialist) to join our team in Moreno Valley.

The incumbent will be responsible for ensuring that research conducted at RUHS protects human subjects, and adheres to Federal, California, and County of Riverside regulations in human subjects protection. The incumbent will also be responsible for ensuring that non-research activities under the IRB's purview (e.g., expanded access, humanitarian use devices) also adhere to Federal and State regulations. The incumbent will review IRB submissions, and make determinations on exempt, expedited, and not human subjects research (e.g., quality improvement projects), as well as determining research that requires full Board review at a convened meeting. As the primary/initial point of contact for the IRB, the position includes service-oriented, timely communication with a range of internal and external stakeholders informing them of IRB requirements and rationale for decisions. The Research Specialist II (IRB Specialist) will also assist with facilitating convened meetings, as well as rigorous documentation of the IRB's determinations for all levels of review (exempt, expedited, full Board, etc.).
Desired Qualifications:

• Master's degree in social science, health sciences, healthcare/public administration or public health which included graduate-level courses in research design and qualitative and quantitative data collection methods.
• Must have experience working on regulatory and compliance aspects of socio-behavioral research and clinical trials, including industry-sponsored or federally funded trials (drugs and/or devices) in a hospital or academic medical setting.
• Experience in research administration, including IRB submissions.
• Breadth of knowledge of Federal and California Institutional Review Board (IRB) policies and procedures.
• Experience interpreting how complex regulatory requirements apply to research and IRB functions.
• Certified IRB Professional (CIP) from PRIM&R, Certified Clinical Research Associate (CCRA) from ACRP, Certified Clinical Research Professional (CCRP) from SOCRA, or an equivalent certification.
• Previous IRB experience in an academic medical center or a hospital setting, including the use of an electronic IRB submission system.

Work Schedule:
9/80 Friday - Day Shift. This position will primarily work remotely with a limited requirement to be on the RUHS Medical Center campus at the department's discretion.

Meet the Team!
RUHS Website

*This is a continuous posting and will remain open until the position is filled. Applications will be reviewed and competitive candidates will be referred for interview in the order in which they are received.*

• Conduct exempt or expedited reviews for new and existing biomedical and socio-behavioral research, including ensuring that all documents are included in the submission and meet regulatory compliance requirements, including reviewing research proposals/protocols, consent forms/HIPAA authorizations, recruitment material, etc. Compose IRB correspondence (e.g., letters to investigators, including approvals, requests for modifications to research, compliance issues, etc.), This is estimated to entail 50% of this role.
• Assist with IRB meetings, including arranging meetings, creating agendas, polling members on meeting attendance, ensuring quorum is maintained during meetings, providing regulatory guidance to IRB members during meetings, preparing minutes, etc. The Research Specialist II (IRB Specialist) will also serve as an alternate IRB member who conducts expedited reviews.
• Respond to inquiries from internal (e.g., resident physicians and pharmacists, attending physicians, Medical Executive Committee, Contracts, County Counsel) and external sources (CITI, IRBNet, external investigators, FDA/OHRP). Meet with investigators (remotely) to discuss IRB submissions when requested. This also includes: troubleshooting access and upload issues with our electronic submission system (IRBNet); providing guidance on executing Data Transfer and Use Agreements; assisting with executing IRB reliance agreements; paying invoices; issuing invoices for sponsored research; monitoring general IRB email accounts.
• Maintain IRB records, including minutes, official IRB roster, records of CITI training, and CVs for investigators and research staff. This will include ensuring that all pertinent documents (e.g., research protocols) and official correspondence (e.g., to PIs) are uploaded to IRBNet and/or SharePoint to ensure official record-keeping meets regulatory requirements.
• Monitor IRBNet for new submissions, training submissions, expired studies, and emails with "return to sender" to ensure submissions are reviewed in a timely and service-oriented manner.
• Assist with developing policies and procedures to ensure continuous quality improvement of an effective human research protection program, including the implementation of any emerging changes to regulatory requirements, and renewing and editing existing Standard Operating Procedures (SOPs).
• Work with the IRB Chair and other Board members to facilitate their onboarding, education, and ongoing membership, as well as the execution of their IRB duties and maintenance of regulatory requirements (e.g., assign reviewers, and ensure members conduct reviews of assigned studies).
• Provide education to Principal and Co-Investigators, and research staff on research regulatory requirements on a one-on-one or group basis.
• Performs other IRB administrative duties as assigned

OPTION I

Education: Graduation from an accredited college or university with a master's degree in social science, statistics, mathematics, economics, business/public administration, public health, data processing, or any of the natural sciences, which included graduate-level courses in research design, data collection methods, and advanced statistical analysis. (Additional qualifying experience may be substituted for up to two years of the required education, based on 10 semester or 15-quarter units of graduate-level course work equaling 6 months.)

Experience: Two years of progressively responsible experience in administrative, professional, investigative, technical, or other responsible work, which included statistical analysis, research or program design and data collection, and electronic data storage and report generation or grant writing.

OPTION II

Education: Graduation from an accredited college or university with a master's degree in social science, statistics, mathematics, economics, business/public administration, public health, data processing, or any of the natural sciences, which included graduate level courses in research design, data collection methods, and advanced statistical analysis. (Additional qualifying experience may substitute for up to two years of the required education, on the basis of 10 semester or 15-quarter units of graduate level course work equaling six months.)

Experience: Two years as a Research Specialist I in Riverside County in a Department of Public Social Services, Public Health, Behavioral Health, Emergency Management, Probation, hospital, or clinical research center.

OPTION III

Education: Graduation from an accredited college or university with a Ph.D. in social science, statistics, mathematics, economics, business/public administration, public health, data processing, or any of the natural sciences, which included graduate-level courses in research design, data collection methods, and advanced statistical analysis.

License: Possession of a valid California Driver's License is required. Additionally, a certification in one of the following is preferred: Certified IRB Professional (CIP) from PRIM&R, Certified Clinical Research Associate (CCRA) from ACRP, Certified Clinical Research Professional (CCRP) from SOCRA, or an equivalent certification. If the CIP designation has not already been obtained, the hiring department expects the incumbent to acquire it upon meeting the eligibility criteria, which include a minimum of 2 years of direct IRB experience.For questions regarding this recruitment please contact the recruiter, Jill Eastman at JEastman@rivco.org