Under administrative direction, leads the implementation and management of the Institutional Review Board (IRB) Quality Assurance Review (QAR) and education programs at Saint Louis University concerning all matters of human subjects research; ensures quality standards have been followed for safety and regulatory compliance; supervises and facilitates reliance requests; manages electronic protocol software; oversees and leads educational and training initiatives for researchers, IRB members, and HRPP staff.

Job Duties:

• Directs all quality assurance efforts, including PI quality assurance reviews (QAR), internal quality assurance reviews (IQAR) assessing effectiveness of the HRPP, policies, and procedures; monitors human subject research protocols for measures of overall compliance; performs and oversees for-cause and noncompliance audits; prepares analysis/summary of results, identifies alternatives for resolution of issues, and develops and monitors corrective and preventative action plans (CAPA); ensures results are accurately reported with appropriate follow-up to close any identified gaps in compliance and to ensure safety and protection of human research subjects.

• Manages development and presentation of training and seminars to faculty, staff, and students pertaining to research issues and institutional review requirements and processes, including but not limited to new principal investigator (PI) training, new investigator mentoring program, coordinator proficiency training, and site initiation visits (SIV); interfaces with Research Directors throughout the University to identify educational needs and ensure sufficient awareness training is provided to active researchers.

• Interfaces with School of Medicine leadership to ensure sufficient awareness training is provided to medical students, residents, and fellows; develops and/or supports human subjects training programs for graduate students in all colleges and schools.

• Manages and provides for complete onboarding and offboarding of members recruited to serve on the IRB; organizes and implements continuing education initiatives for HRPP staff and board members.

• Supervises and 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; develops and implements new methods and procedures necessary to ensure complete compliance while facilitating timely approval for SLU sites, achieving operational efficiencies, and reducing internal regulatory burden.

• Oversees and develops inter-institutional agreements for review of human subjects research protocols to be conducted in collaboration with affiliate institutions; interfaces directly with external entities and SLU internal entities including but not limited to Office of General Counsel, Office of Vice President for Research, School of Medicine and other client schools and departments to review, negotiate terms and facilitate the execution of IRB reliance agreements.

• Directs efforts to attain accreditation for the SLU HRPP by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and ensures successful accreditation renewals.

• Develops metrics to identify areas for improvement in the initiation and conduct of research as it specifically relates to HRPP operations and research compliance; prepares institutional reports to the Office of Vice President for Research, SSM Health St. Louis, and other collaborating entities.

• Oversees and directly manages IRB protocol software, including updates and testing; responsible for ensuring data integrity, accuracy of reports, and software vendor accountability; coordinates with the HRPP Director to ensure operational functionality of software.

• Manages or oversees HRPP websites, including intranet; ensures all on-line documentation is up-to-date and easily navigable for end user access.

• Assists with the hiring, supervision, and training of HRPP staff, which may include Analysts, Coordinators, or other support positions.

• Performs other duties as assigned.

Knowledge, Skills, Abilities, and Personal Characteristics:

• 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, research methodology and design with relevant experience conducting, reviewing, and/or monitoring research involving human participants or research program coordination/administration

• 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

• Managerial and supervisory 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

• Cooperative and positive attitude in contributing to the team

Qualifications:

Bachelors degree; with at least three (3) years of human subjects research related experience requiring substantial and ongoing performance of IRB administrative functions and duties; with five (5) or more years of current and relevant experience conducting, reviewing, and/or monitoring research involving human subjects; must hold CIP (Certified IRB Professional) certification; relevant Association of Clinical Research Professionals (ACRP), American Society for Quality (ASQ), Health Care Compliance Association (HCCA) certification or equivalent preferred; masters degree preferred.

Saint Louis University requires COVID-19 vaccinations and a booster dose for all students, staff, and faculty who are physically present on our St. Louis campuses. As a prospective and/or a new employee at Saint Louis University, you will be/are required to comply with the Universitys vaccination protocol. Proof of full vaccination is required before the start of employment in order to work at Saint Louis University. If you are not vaccinated, you are required to begin the vaccination process at the time of your first day of employment and submit proof of full vaccination within 30 days of your start date. Exemptions may be granted on the grounds of religious beliefs or medical circumstances. Failure to comply with the vaccine requirement within 30 days of an employees start date will result in termination of the employment.  Proof of vaccine will be submitted through an online portal made available to you during your Workday onboarding tasks.

The University will require all students, faculty and staff to obtain a booster vaccine dose prior to their start date, This applies to:
â¢Â Â   All adults over the age of 18 years who completed their vaccine series with Pfizer or Moderna at least 6 months ago.  
â¢Â Â   Those who received the J&J vaccine at least two months ago.