Quality and Compliance Coordinator.IRB

2 weeks ago

New Orleans, LA, United States Tulane University Staff Full time

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.
• 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.

• 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).

• 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.

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