IRB Analyst II

Saint Louis University•SLU Saint Louis, MO

1d•Onsite

About The Position

Saint Louis University (SLU), a prestigious Catholic university founded in 1818, is seeking an IRB Analyst II to coordinate daily activities for processing research protocols and managing protocol review. This role supports the Institutional Review Board (IRB) and Human Research Protection Program (HRPP) by performing audits, assisting with educational activities related to human subjects protections, and training HRPP staff. SLU is known for its world-class academics, life-changing research, compassionate health care, and commitment to faith and service.

Requirements

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.
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.

Nice To Haves

Master's degree

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 the difficulty level of protocol issues and regulatory determinations.
Prepares protocols for IRB action, delineates revision requirements, and reviews investigators’ responses.
Makes decisions for approval and aids 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 SLU workflows and guidelines are followed and meet current federal regulations.
Coordinates IRB meetings, prepares agendas and materials, reviews materials with HRPP Director and Chairs, and prepares draft meeting minutes.
Documents IRB review determinations, monitors existing and new protocols, and gathers information to make approval decisions.
Responds to requests for information regarding IRB review.
Assists with quality assurance efforts, including PI quality assurance reviews (QAR) and for-cause and noncompliance audits.
Monitors human subject research protocols for 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 for AAHRPP accreditation.
Assists in the development and presentation of training and seminars to faculty, staff, and students.
Serves as liaison to assigned academic units and supports researchers through the IRB process.
Attends workshops and conferences on current issues affecting IRB oversight.
Informs Director of issues raised by the IRB or researchers.
Assists with the training of HRPP staff.
Performs internal quality assurance reviews (iQARs) of work completed by Analysts I and II and provides constructive feedback.
Performs other duties as assigned.