Program Manager, HRPP Regulatory Operations

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 Program Manager, HRPP Regulatory Operations will be responsible for executing education program activities, conducting substantive pre-submission intake reviews, and providing IRB review and quality assurance support as it relates to the Human Research Protection Program (HRPP) at Saint Louis University. This position focuses on developing and implementing continuous improvement efforts related to human subjects research education and contributing to institutional initiatives to obtain and maintain Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation. PRIMARY JOB RESPONSIBILITIES Executes and evaluates the education program to ensure research is conducted in accordance with applicable regulations, laws, and policies; monitors changes in laws, regulations, and technology and communicates potential operational impacts to management; identifies gaps in educational and training initiatives for researchers and develops resources, guidance documents, and support materials to meet research needs; maintains and tracks education program records that are subject to professional and technical audit Reviews and processes incoming submissions by verifying compliance with unit policies and routing submissions to required University ancillary groups for review; conducts structured pre-submission intake reviews to provide investigators with early, substantive feedback to identify missing elements, clarify regulatory requirements, and improve submission quality before formal IRB assignment; uses patterns and trends identified through intake review to inform the development of targeted guidance documents, researcher training materials, and educational resources that address common submission deficiencies and regulatory misunderstandings; reviews post-approval submissions; processes out human subjects research applications Conducts protocol review across all submission types in support of IRB review activities; may serve as a Designated Reviewer when formally appointed by the IRB Chair in accordance with IRB policies and procedures; assists with quality assurance activities related to researcher conduct of approved studies, including PI quality assurance reviews (QAR), for-cause and noncompliance audits, and CAPA development and monitoring for researcher-directed corrective actions; ensures appropriate separation of duties between IRB review and QA activities Coordinates Institutional Review Board meetings and other meetings as directed; contacts Board members to solicit timely submission of reviews; documents review determinations in protocol files; maintains committee rosters and facilitates member on- and off-boarding; coordinates quality assurance review (QAR) and research monitoring program visits; processes pre- and post-QAR visit documentation and reports; facilitates the execution and maintenance of HRPP-related agreements in accordance with federal regulations Develops and delivers training and seminars to faculty, staff, and students pertaining to research issues, submission requirements, and regulatory compliance; develops and delivers targeted educational sessions addressing common submission deficiencies and regulatory requirements identified through the intake review process; organizes and implements continuing education initiatives for HRPP staff and board members; identifies educational needs across research departments to ensure sufficient awareness training is provided to active researchers Contributes to efforts to attain and renew AAHRPP accreditation by developing and maintaining required documentation and materials; develops and optimizes HRPP forms, templates, workflows, and standard operating procedures to improve operational efficiency and ensure alignment with regulatory requirements and accreditation standards Coordinates the ongoing training and professional development of HRPP staff, which may include Analysts, Coordinators, or other support positions; provides structured onboarding and competency training for newly hired HRPP staff Performs other duties as assigned KNOWLEDGE, SKILLS, AND ABILITIES 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 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 Cooperative and positive attitude in contributing to the team MINIMUM QUALIFICATIONS Bachelor’s degree Three or more years of human subjects research related experience requiring substantial and ongoing performance of HRPP administrative functions and duties Five or more years of current and relevant experience conducting, reviewing, and/or monitoring research involving human subjects; or equivalent combination of education and/or experience Must be eligible for CIP (Certified IRB Professional) certification PREFERRED QUALIFICATIONS Master's degree CIP (Certified IRB Professional) Relevant research-related quality assurance or clinical research certifications, such as CCRA (Certified Clinical Research Associate), CCRP (Certified Clinical Research Professional), or equivalent Function Research Support 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.