Tulane University
Quality and Compliance Coordinator.IRB
Tulane University, New Orleans, Louisiana, United States, 70123
Overview
The IRB Quality and Compliance Coordinator ensures that research projects meet regulatory and ethical standards by providing professional consultation to researchers and to the Institutional Review Board (IRB) or any other boards that regulate research. An IRB Quality and Compliance Coordinator ensures that researchers comply with regulations, ethical standards, and institutional procedures to protect human subjects through a robust education, training and outreach program, which includes but is not limited to Post Approval Monitoring responsibilities and initiatives. The targeted audience for the IRB Quality and Compliance Coordinator's training initiatives are research faculty and staff, IRB Members, and HRPO personnel. The position also oversees the review of reportable events and presents to the IRB as needed. The position provides consultation to researchers and board members on regulatory and procedural compliance, in accordance with the HRPO SOPs. The position develops and delivers compliance training programs to prevent non-compliance during the conduct of research. Responsibilities
Provide professional consultation to researchers and to the Institutional Review Board (IRB) or other boards that regulate research to ensure regulatory and ethical standards are met. Oversee Post Approval Monitoring responsibilities and initiatives. Develop and deliver compliance training programs to prevent non-compliance during the conduct of research. Lead training initiatives for research faculty and staff, IRB Members, and HRPO personnel. Review reportable events and present to the IRB as needed. Provide consultation to researchers and board members on regulatory and procedural compliance per HRPO SOPs. Ensure researchers comply with regulations, ethical standards, and institutional procedures to protect human subjects. Required Knowledge, Skills, And Abilities
Ability to effectively research and interpret regulations (federal, state, local, and international), institutional policies, and accrediting body standards applicable to research. Working knowledge of word processing and database software; specific experience using Microsoft Word, PowerPoint, Access, and other Windows-based applications. Excellent organizational and communication skills. Ability to communicate articulately with researchers, senior administration, regulators, and sponsors. Ability to meet established deadlines and make decisions independently. Ability to assist and provide guidance to co-workers. Highly organized and detail-oriented. Ability to work on multiple projects simultaneously and prioritize projects. Ability to maintain confidentiality in all work performed. Ability to work evenings and weekends, as needed. Ability to travel, as needed. Required Education And/or Experience
Bachelors Degree and three (3) years of human subjects clinical research experience, including legal and/or regulatory research experience. OR High School Diploma/Equivalent with nine (9) years of human subjects clinical research experience, including legal and/or regulatory research experience. Within two (2) years of hire date, must attain at least one of the following certifications: IRB Professional Certification (CIP) or Healthcare Research Compliance Certification (CHRC). Preferred Qualifications
Juris Doctorate or other advanced degree, or a combination of Bachelors Degree with three to five years of experience working in human subjects research either in the capacity as a researcher or research management. Three to five years of experience working under or with regulatory statues, guidance, policies, and standard operating procedures pertaining to research. Knowledge of HIPAA. Experience with writing policies and standard operating procedures. Public speaking experience. Certified Institutional Review Board (IRB) Professional (CIP) or other certification related to research administration or oversight. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Higher Education
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The IRB Quality and Compliance Coordinator ensures that research projects meet regulatory and ethical standards by providing professional consultation to researchers and to the Institutional Review Board (IRB) or any other boards that regulate research. An IRB Quality and Compliance Coordinator ensures that researchers comply with regulations, ethical standards, and institutional procedures to protect human subjects through a robust education, training and outreach program, which includes but is not limited to Post Approval Monitoring responsibilities and initiatives. The targeted audience for the IRB Quality and Compliance Coordinator's training initiatives are research faculty and staff, IRB Members, and HRPO personnel. The position also oversees the review of reportable events and presents to the IRB as needed. The position provides consultation to researchers and board members on regulatory and procedural compliance, in accordance with the HRPO SOPs. The position develops and delivers compliance training programs to prevent non-compliance during the conduct of research. Responsibilities
Provide professional consultation to researchers and to the Institutional Review Board (IRB) or other boards that regulate research to ensure regulatory and ethical standards are met. Oversee Post Approval Monitoring responsibilities and initiatives. Develop and deliver compliance training programs to prevent non-compliance during the conduct of research. Lead training initiatives for research faculty and staff, IRB Members, and HRPO personnel. Review reportable events and present to the IRB as needed. Provide consultation to researchers and board members on regulatory and procedural compliance per HRPO SOPs. Ensure researchers comply with regulations, ethical standards, and institutional procedures to protect human subjects. Required Knowledge, Skills, And Abilities
Ability to effectively research and interpret regulations (federal, state, local, and international), institutional policies, and accrediting body standards applicable to research. Working knowledge of word processing and database software; specific experience using Microsoft Word, PowerPoint, Access, and other Windows-based applications. Excellent organizational and communication skills. Ability to communicate articulately with researchers, senior administration, regulators, and sponsors. Ability to meet established deadlines and make decisions independently. Ability to assist and provide guidance to co-workers. Highly organized and detail-oriented. Ability to work on multiple projects simultaneously and prioritize projects. Ability to maintain confidentiality in all work performed. Ability to work evenings and weekends, as needed. Ability to travel, as needed. Required Education And/or Experience
Bachelors Degree and three (3) years of human subjects clinical research experience, including legal and/or regulatory research experience. OR High School Diploma/Equivalent with nine (9) years of human subjects clinical research experience, including legal and/or regulatory research experience. Within two (2) years of hire date, must attain at least one of the following certifications: IRB Professional Certification (CIP) or Healthcare Research Compliance Certification (CHRC). Preferred Qualifications
Juris Doctorate or other advanced degree, or a combination of Bachelors Degree with three to five years of experience working in human subjects research either in the capacity as a researcher or research management. Three to five years of experience working under or with regulatory statues, guidance, policies, and standard operating procedures pertaining to research. Knowledge of HIPAA. Experience with writing policies and standard operating procedures. Public speaking experience. Certified Institutional Review Board (IRB) Professional (CIP) or other certification related to research administration or oversight. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Higher Education
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