IRB Analyst II

Saint Louis University; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Saint Louis University is seeking an IRB Analyst II to coordinate daily processing of research protocols and assist the IRB and HRPP in review management. You will perform audits, monitor compliance, and support staff training. The role involves facilitating central IRB reviews, ensuring adherence to FDA, OHRP, ICH/GCP rules, and preparing meeting materials.

Strong analytical and communication skills are essential, with teamwork and confidentiality. Scheduled weekly hours are 40.

Qualifications

• Bachelor's degree required; CIP certification preferred.
• Two or more years of experience in human subjects research or related monitoring.
• Familiarity with IRB processes, AAHRPP standards, and federal regulations.

Responsibilities

• Reviews and processes exempt and expedited protocol submissions as an IRB designee.
• Coordinates the review process of protocol submissions with IRB reviewers and ancillary office reviewers.
• Determines difficulty level of protocol issues and regulatory determinations.
• Prepares protocols for IRB action and delineates revision requirements.
• Reviews investigators' responses and makes decisions for approval.
• Assists with training HRPP staff and monitors compliance across protocols.
• Facilitates review of central IRBs, external IRBs, and single IRB submissions.
• Coordinates IRB meetings, prepares agenda, and documents review determinations.

Skills

Regulatory compliance

ICH/GCP guidelines

HIPAA knowledge

Analytical skills

Verbal and written communication

Education

Bachelor's degree

Master's degree

CIP Certification

Tools

Microsoft Office

HR database software

Job description

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation's oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

JOB SUMMARY

The IRB Analyst II coordinates the daily activities associated with the processing of research protocols and all facets of protocol review management to assist the Institutional Review Board (IRB) and Human Research Protection Program (HRPP); performs audits and monitoring visits under the IRB's Quality Assurance Review (QAR) program; assists institutional research educational activities related to human subjects protections; assists with the training of HRPP staff.

PRIMARY JOB RESPONSIBILITIES

• Reviews and processes exempt and expedited protocol submissions as an IRB designee;
• coordinates the review process of protocol submissions with IRB reviewers and, when deemed necessary, ancillary office reviewers;
• determines difficulty level of protocol issues and regulatory determinations;
• prepares protocols for IRB action;
• delineates revision requirements;
• reviews investigators' responses;
• makes decisions for approval;
• aid reviewers' and HRPP Director in approval decisions;
• processes or administratively withdraws protocols based on established guidelines
• Facilitates the review of all central IRBs, external IRBs, and single IRB submissions;
• reviews HRPP policies/procedures relative to central IRBs, external IRBs, and single IRB submissions to ensure that all SLU workflows and guidelines are followed and meet current federal regulations
• Coordinates IRB meetings; prepares agenda and materials to meet distribution deadlines; reviews materials with HRPP Director and Chairs; prepares draft meeting minutes; documents IRB review determinations; monitors existing and new protocols; gathers information and background material in response to inquiries/issues raised and to make approval decisions; responds to requests for information regarding IRB review
• Assists with all quality assurance efforts, including PI quality assurance reviews (QAR) and for-cause and noncompliance audits; monitors human subject research protocols for measures of overall compliance; assists with the analysis/summary of results, identification of alternatives for resolution of issues, and development and monitoring of corrective and preventative action plans (CAPA)
• Assists with revisions and implementation of HRPP forms, policies, guidelines, and standard operating procedures; assists with development of materials required for attaining and renewing accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP); assists in the development and presentation of training and seminars to faculty, staff, and students pertaining to research issues and institutional review requirements and processes
• Serves as liaison to assigned academic units; supports researchers through the IRB process; attends workshops and conferences focused on current issues affecting the IRB oversight of the protection of human subjects in research; informs Director of issues raised by the IRB or researchers
• Assists with the training of HRPP staff, which may include Analysts I, Coordinators, or other support positions; performs internal quality assurance reviews (iQARs) of the work completed by Analysts I and II and provides constructive feedback
• Performs other duties as assigned

KNOWLEDGE, SKILLS, AND ABILITIES

Extensive knowledge of ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPAA Privacy Rule, and HRPP policies and guidelines related to human subject protection, medical and clinical terminology, and research methodology and design
Strong analytical skills with ability to identify issues and solve problems within the framework of federal and state regulations, accreditation standards and institutional requirements
Excellent verbal and written communication skills
Professional demeanor with ability to work both collaboratively and independently, to maintain confidentiality, and to provide excellent customer service
Ability to operate personal computers, Microsoft Office products, and customized data base software
Good organizational skills with ability to work on multiple projects simultaneously
Flexibility and ability to adapt to a changing environment

MINIMUM QUALIFICATIONS

• Bachelor's degree
• Two or more years of current and relevant experience conducting, reviewing, and/or monitoring research involving human subjects
• Must hold CIP (Certified IRB Professional) certification

PREFERRED QUALIFICATIONS

Master's degree

Scheduled Weekly Hours: 40

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.

Saint Louis University is a premier employer in the St. Louis region that attracts faculty and staff from around the world. We recruit people of all faiths who share our mission to pursue truth for the greater glory of God and the service of others.