Purpose of Position and Scope of Responsibility:
In support of Baptist's mission and Human Research Protections Program, the IRB Quality Monitor is charged with facilitating the proper conduct of IRB-approved studies with a core focus on Good Clinical Practice Guidelines (GCP) and the advice of the legal arm of the Department of Health and Human Services (HHS), the Office of the General Counsel (OGC). The position requires using knowledge of research regulations, guidance, and practice standards and applying this knowledge across a diverse portfolio of research. The purpose of this position is to provide a systematic, internal process that will increase compliance with federal, state, and institutional requirements and ensure that research staff follow the approved protocol and apply the ethical principles outlined in the Belmont Report. Responsibilities include quality assurance monitoring of human research and IRB activities to confirm the conduct and oversight of research comply with regulations and follow professional best-practice standards. This proactive approach will minimize risks to human subjects and minimize regulatory risks at the investigator and organizational levels. Principal Accountabilities/Responsibilities:
• Identify trends and areas of potential risk by:
-monitoring correspondence and reports from OHRP, FDA, and other sources of regulatory information;
-monitoring reports to and correspondence from internal and external IRBs;
-tracking internal QA/QI activities; and
-creating customized audit reports for protocol-specific benchmark requirements.
• In collaboration with the Assistant Director of the HRPP, assess the level of risk associated with audit/review findings by using knowledge of research regulations, guidance, practice standards, and exercising good judgment. Facilitate and prepare any applicable mandatory reporting requirements to regulatory bodies.
• Monitor research and IRB activities for compliance with applicable federal regulations and guidelines, IRB requirements, and Baptist HRPP Policies and Procedures by:
-performing periodic compliance reviews of human research studies and IRB activities under the HRPP QA/QI Plan;
-providing investigators with QI recommendations and targeted training to ensure compliance;
-providing the IRB with QI recommendations and targeted training to ensure that review and oversight activities align with regulations, guidance, and practice standards;
-assisting investigators and the IRB with the development of Corrective and Preventative Action (CAPA) Plans as warranted;
-preparing written reports that detail observations, regulatory risks, recommendations, and any other actions necessary to bring the research or IRB activity into compliance; and
-reporting potential serious or continuing non-compliance with applicable regulations or institutional policies to the appropriate Baptist leadership.
• Review EMR/medical records of research participants, judge the impact of any non-compliance on study plans/processes, and communicate findings to investigators.
• Report monitoring plans and QA findings to various committees regularly.
• Assist investigators, the IRB, and other stakeholders in preparing for external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities by:
-providing training on what to expect, how best to prepare materials, and how to interact with auditors or inspectors;
-interviewing personnel and reviewing records in advance to identify possible areas of concern to address issues proactively; and
-providing support and guidance to investigators and staff throughout the audit or inspection.
• Develop and provide educational programs, training, and materials for the research community by:
-monitoring relevant federal and state regulations and guidance documents;
-interacting with different departments and facilitating a comprehensive, accessible program that provides CMEs, CEUs, and other credits as appropriate; and
-providing training on the electronic IRB submission system.Qualifications:RequirementsMinimum Qualifications
Bachelor's Degree required; Master's Degree preferred.
Min 3 to 5 years of work experience in research, IRB, or HRPP
Candidates for this position should have:
• experience with human research;
• good interpersonal and communication skills;
• experience reporting on complex topics with investigators, research staff, IRB members, senior leadership, sponsor representatives, accrediting organizations, and federal regulating authorities;
• acute attention to detail and the ability to interpret complex regulations and standards;
• knowledge of federal regulations (21 CFR 50, 56, 312, 812; 45 CFR 46, and HIPAA), guidance, and industry best-practices for human research;
• excellent organizational skills; and
• the ability to:
-apply regulatory knowledge across a diverse research portfolio;
-simplify complex analysis and tailor presentations for various audiences, including staff, senior leaders, and IRB members;
-develop and lead educational programs designed for groups and individuals;
-manage conflicting demands and priorities without compromising quality;
-work independently; and
-effectively balance team and individual responsibilities.
Experience as a monitor or auditor for industry trials preferred.
Licensure, Registration, Certification
Must obtain one of the following certifications within 2 years of employment:
PRIM&R certified CIP; or
ACRP certified CCRA, CCRC, or ACRP-CP; or
SOCRA certified CCRP.
Expertise using software such as Word, Excel, Access, PowerPoint, SharePoint, and EPIC. Physical Requirements:
Work requires the physical demands of standing, bending, lifting, and performing other work requiring light physical exertion (up to 30 pounds) in addition to frequent walking and digital dexterity. Some travel may be required.