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Tulane University · 4 months ago

Quality and Compliance Coordinator.IRB

New Orleans, LA

Full-time

Onsite

Mid Level

3+ years exp

Tulane University is seeking an IRB Quality and Compliance Coordinator who ensures that research projects adhere to regulatory and ethical standards. The role involves providing consultation to researchers and the Institutional Review Board, overseeing compliance training programs, and reviewing reportable events to maintain the integrity of research practices.

BiotechnologyHealth Care

Responsibilities

Ensure 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

Ensure 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

Oversee the review of reportable events and present to the Institutional Review Board (IRB), as needed

Provide consultation to researchers and board members on regulatory and procedural compliance, in accordance with the HRPO SOPs

Develop and deliver compliance training programs to prevent non-compliance during the conduct of research

Qualification

IRB Professional CertificationHealthcare Research Compliance CertificationHuman subjects clinical researchRegulatory compliance knowledgePolicy writing experiencePublic speakingOrganizational skillsCommunication skillsConfidentiality maintenance

Required

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

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

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

Company

Tulane University

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A member of the prestigious Association of American Universities, Tulane University is consistently ranked among the top 50 universities in the nation.

Founded in 1964

Covington, Louisiana, USA

1001-5000 employees