IRB Specialist

Ochsner Health • New Orleans, LA

4d

About The Position

We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways. At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today! This job performs thorough review of human subjects' research studies submitted to the Institutional Review Board (IRB) office for the purposes of ensuring compliance to regulatory requirements, clarity of informed consents and completeness of IRB application forms. Works in coordination with investigators and research coordinators to ensure completeness and quality of submissions to IRB Panels for review; and manages database, generates formal letters, and instructs individuals for investigators and coordinators on the IRB process and use of IRB database. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties. This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

Requirements

• Education Required - Bachelor's degree.
• Work Experience Required - 2 years of relevant research or IRB experience.
• Certifications Required - Certification in IRB by the Council for Certification of IRB Professionals (CCIP) and PRIM&R (Public Responsibility in Medicine & Research). If certification is not currently held, incumbent must obtain certification within 12 months of hire if eligible at time of hire, or within 12 months of becoming eligible to test for certification
• Knowledge Skills and Abilities (KSAs) Proficiency in using computers, software, and web-based applications.
• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Good organizational skills and ability to be detail-oriented.
• Excellent interpersonal skills.
• Ability to travel throughout and between facilities.

Nice To Haves

• Preferred - Advanced degree.

Responsibilities

• Reviews research study submissions prior to IRB review for completeness and compliance to regulatory requirements.
• Reviews and edits research study consent forms for completeness, readability and format.
• Ensures integrity and security of IRB data.
• Provides support to investigators and coordinators in the IRB application process and use of the IRB online submission forms.
• Supports departmental goals and seeks opportunities to improve work processes.
• Performs other related duties as required.
• Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.
• This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees