County of Riverside · 3 hours ago
Research Specialist II - Human Research Protection Program
Riverside County, CA
Full-time
Remote
Entry, Mid Level
2+ years exp
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Responsibilities
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
Qualification
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Required
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.
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.
Previous IRB experience in an academic medical center or a hospital setting, including the use of an electronic IRB submission system.
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.
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.
Possession of a valid California Driver's License.
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.
Company
County of Riverside
We are seeking passionate people who are committed to solving critical issues while realizing their purpose! Riverside County is the fourth largest county in the State of California, stretching nearly 200 miles across and comprising over 7,200 square miles of fertile river valleys, low deserts, mountains, foothills and rolling plains.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Brian Nestande
Deputy CEO
Charissa Leach, P.E.
Riverside Co. Asst. Chief Executive Officer/TLMA Director
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