Marymount University
IRB Coordinator
Marymount University is seeking a qualified, experienced, and detail-oriented IRB Coordinator to oversee the daily operations of the Institutional Review Board (IRB). This position plays a vital role in ensuring university-wide compliance with federal regulations and ethical standards for the protection of human subjects in research. Therefore, it is an on-site position. The salary range for this position is $52,000 - $58,000 per year. Department: Office of Research Marymount University
Arlington, VA Position Type: Full-Time, In-person, Exempt (Administrative Staff) Reports To: IRB Chair and Vice President for Research Position Summary: The IRB Coordinator serves as the primary liaison between the IRB and investigators, managing protocol submissions, continuing reviews, amendments, and compliance documentation. All IRB processes are conducted through Sitero Mentor, Marymount's IRB application and review system. The IRB Coordinator will work closely with the IRB Chair and board members, as well as key institutional offices and stakeholdersOffice of Research, Office of Sponsored Programs (OSP), Office of Research Development and Education Support (ORDES), Legal Counsel, Colleges and academic departmentsto support ethical and responsible research practices and promote a culture of research integrity across the university. Key Responsibilities: Coordinate the submission, screening, review, and tracking of all IRB applications using Sitero Mentor platform. Review protocol submissions for completeness and appropriate level of review (exempt, expedited, full board). Provide regulatory guidance to faculty, staff, and students regarding human subjects protections, informed consent, protocol development, and compliance requirements. Schedule and support IRB meetings: prepare agendas, confirm quorum, record and maintain meeting minutes, and document IRB determinations. Coordinate IRB meetings and confirm attendance to ensure quorum is met. Monitor timelines for protocol renewals, amendments, adverse events, and final reports; ensure timely investigator communication. Manage the IRB Email Inbox: Monitor and organize incoming communications; respond to general inquiries or route messages to appropriate personnel. Respond to questions about Sitero Mentor navigation, IRB submissions, and processes; provide guidance on application requirements and procedures. Coordinate Sitero Mentor Platform use and assist users with navigation, troubleshoot issues, and provide support documentation or walkthroughs when needed. Ensure institutional compliance with 45 CFR 46 (Common Rule), HIPAA Privacy Rule, FDA regulations (as applicable), and university policies. Maintain up-to-date IRB policies, procedures, templates, and training materials. Coordinate and track CITI Program training completion for investigators. Prepare for internal and external audits and maintain organized records for regulatory reporting and federal assurance filings (e.g., FWA). Collaborate with the Office of Research (OR), Office of Sponsored Programs (OSP), Office of Research Development and Education Support (ORDES), legal counsel, and academic departments to support research integrity. Use Workday to ensure alignment of personnel roles and compliance training records. Maintain Regular Office Hours and be available during scheduled hours to support IRB related inquiries and administrative tasks. Communications with IRB reviewers, track review assignments, and follow up to ensure timely completion. Qualifications Required: Bachelor's degree in a relevant field (e.g., health sciences, public health, psychology, sociology, research administration). 13 years of experience in IRB administration, research compliance, or human subjects protections. Demonstrated knowledge of federal research regulations, including 45 CFR 46 (Common Rule). Completion of Human Subjects Research (HSR) training via the CITI Program (or willingness to complete upon hire). Familiarity with clinical research protocols and Good Clinical Practice (GCP) training requirements. Experience coordinating IRB reviews in a university or academic medical center setting. Understanding of NIH single IRB (sIRB) policy and cooperative research agreements. Familiarity with federal assurance processes, such as FWA (Federalwide Assurance) management. Preferred: Certified IRB Professional (CIP) credential (or eligibility to obtain the certification). Proficiency with IRB protocol management systems; experience with Sitero Mentor. Strong organizational, communication, and interpersonal skills with attention to detail and confidentiality. Proficiency with Microsoft Office Suite and experience using enterprise systems like Workday.
Marymount University is seeking a qualified, experienced, and detail-oriented IRB Coordinator to oversee the daily operations of the Institutional Review Board (IRB). This position plays a vital role in ensuring university-wide compliance with federal regulations and ethical standards for the protection of human subjects in research. Therefore, it is an on-site position. The salary range for this position is $52,000 - $58,000 per year. Department: Office of Research Marymount University
Arlington, VA Position Type: Full-Time, In-person, Exempt (Administrative Staff) Reports To: IRB Chair and Vice President for Research Position Summary: The IRB Coordinator serves as the primary liaison between the IRB and investigators, managing protocol submissions, continuing reviews, amendments, and compliance documentation. All IRB processes are conducted through Sitero Mentor, Marymount's IRB application and review system. The IRB Coordinator will work closely with the IRB Chair and board members, as well as key institutional offices and stakeholdersOffice of Research, Office of Sponsored Programs (OSP), Office of Research Development and Education Support (ORDES), Legal Counsel, Colleges and academic departmentsto support ethical and responsible research practices and promote a culture of research integrity across the university. Key Responsibilities: Coordinate the submission, screening, review, and tracking of all IRB applications using Sitero Mentor platform. Review protocol submissions for completeness and appropriate level of review (exempt, expedited, full board). Provide regulatory guidance to faculty, staff, and students regarding human subjects protections, informed consent, protocol development, and compliance requirements. Schedule and support IRB meetings: prepare agendas, confirm quorum, record and maintain meeting minutes, and document IRB determinations. Coordinate IRB meetings and confirm attendance to ensure quorum is met. Monitor timelines for protocol renewals, amendments, adverse events, and final reports; ensure timely investigator communication. Manage the IRB Email Inbox: Monitor and organize incoming communications; respond to general inquiries or route messages to appropriate personnel. Respond to questions about Sitero Mentor navigation, IRB submissions, and processes; provide guidance on application requirements and procedures. Coordinate Sitero Mentor Platform use and assist users with navigation, troubleshoot issues, and provide support documentation or walkthroughs when needed. Ensure institutional compliance with 45 CFR 46 (Common Rule), HIPAA Privacy Rule, FDA regulations (as applicable), and university policies. Maintain up-to-date IRB policies, procedures, templates, and training materials. Coordinate and track CITI Program training completion for investigators. Prepare for internal and external audits and maintain organized records for regulatory reporting and federal assurance filings (e.g., FWA). Collaborate with the Office of Research (OR), Office of Sponsored Programs (OSP), Office of Research Development and Education Support (ORDES), legal counsel, and academic departments to support research integrity. Use Workday to ensure alignment of personnel roles and compliance training records. Maintain Regular Office Hours and be available during scheduled hours to support IRB related inquiries and administrative tasks. Communications with IRB reviewers, track review assignments, and follow up to ensure timely completion. Qualifications Required: Bachelor's degree in a relevant field (e.g., health sciences, public health, psychology, sociology, research administration). 13 years of experience in IRB administration, research compliance, or human subjects protections. Demonstrated knowledge of federal research regulations, including 45 CFR 46 (Common Rule). Completion of Human Subjects Research (HSR) training via the CITI Program (or willingness to complete upon hire). Familiarity with clinical research protocols and Good Clinical Practice (GCP) training requirements. Experience coordinating IRB reviews in a university or academic medical center setting. Understanding of NIH single IRB (sIRB) policy and cooperative research agreements. Familiarity with federal assurance processes, such as FWA (Federalwide Assurance) management. Preferred: Certified IRB Professional (CIP) credential (or eligibility to obtain the certification). Proficiency with IRB protocol management systems; experience with Sitero Mentor. Strong organizational, communication, and interpersonal skills with attention to detail and confidentiality. Proficiency with Microsoft Office Suite and experience using enterprise systems like Workday.