Quality and Compliance Coordinator.IRB

University Human Research Protection Office Location: New Orleans, LA

Summary

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 Institutional Review Board (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. 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 Institutional Review Board (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. 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 various standard word processing and database software required; specific experience using Microsoft Word, PowerPoint, Access, and other windows based applications preferred.
• 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 detailed oriented individual.
• Ability to work on a number of projects simultaneously and ability to prioritize projects.
• Ability to maintain confidentiality in all work performed.
• Ability to work evenings and weekends, as needed.
• Ability to travel, as needed.
• Working knowledge of various standard word processing and database software required; specific experience using Microsoft Word, PowerPoint, Access, and other windows based applications preferred.
• 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 detailed oriented individual.
• Ability to work on a number of projects simultaneously and ability to 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:

• Bachelor's Degree and three (3) years of human subjects clinical research experience, including legal and/or regulatory research experience.

OR

• High School Diploma/Equivalent nine (9) years' 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).

OR

• High School Diploma/Equivalent nine (9) years' 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 Bachelor's 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 the Health Insurance Portability and Accountability Act ("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.
• Three to five years of experience working under or with regulatory statues, guidance, policies, and standard operating procedures pertaining to research.
• Knowledge of the Health Insurance Portability and Accountability Act ("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.
• Knowledge of the Health Insurance Portability and Accountability Act ("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.
• Public speaking experience.
• Certified Institutional Review Board ("IRB") Professional ("CIP") or other certification related to research administration or oversight.

Compensation

Information This position is classified as "exempt, salaried" and is assigned to pay grade null. Tulane offers a variety of options to enhance your health and well-being so that you may enjoy more out of life now and in the future. Learn more about Life at Tulane as well as our Benefits and Pay. See our Candidate Resources to learn more about our hiring process and what to expect. How to Apply: This position will close on the date it is filled Please Note: Depending on your role and the department in which you work, you may be expected to adhere to COVID-19 requirements, such as vaccinations and booster shots. Click "Apply Now" to apply for this job. Tulane University is an equal opportunity educator and employer committed to providing an education and employment environment free of unlawful discrimination, harassment, and retaliation. Legally protected demographic classifications (such as a person's race, color, religion, age, sex, national origin, shared ancestry, disability, genetics, veteran status, or any other characteristic protected by federal, state, or local laws) are not relied upon as an eligibility, selection or participation criteria for Tulane's employment or educational programs or activities. Tulane University is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing an application or during any phase of the interview process, please contact the Office of Human Resources by phone at 504-865-4748 or by email at [email protected]. Apply tot his job Apply To this Job