Director - Human Research Protection Program

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 oversees the strategic planning, administration, and operation of all activities in the Human Research Protections Program (HRPP) at all Ochsner facilities that conduct research.

Oversees the Ochsner Institutional Review Board (IRB) consisting of three panels in partnership with its executive chair.

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.

Education

Required Bachelor's degree.

Preferred Bachelor’s degree in biosciences, life sciences, healthcare, or related field.

Work Experience

Required 8 years leadership and / or management experience in IRB and / or quality assurance within HRPP.

Certifications

Required Certified IRB Professional (CIP) certification within one year of hire.

Knowledge Skills and Abilities (KSAs)

• Proficiency in using computers, software, and web-based applications including eIRB.
• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Strong analytical and problem-solving skills.
• Ability to work a flexible schedule (e.g., 24 / 7, weekend, holiday, on call availability).

Job Duties

• Collaborates with clinical research leadership to ensure IRB and Quality Assurance (QA) functions are fully implemented across all Ochsner research sites and oversees policies, procedures, and improvement initiatives.
• Works with leaders in research administration and clinical departments to establish priorities and strategic imperatives for regulatory compliance and to troubleshoot problem areas and ensures the HRPP office has optimal infrastructure and resources necessary for ensuring regulatory compliance.
• Serves as a point of contact with external IRBs and regulatory agencies such as the Federal Office of Research Integrity and AAHRPP and leads accreditation efforts by regulatory bodies such as AAHRPP.
• Leads development of efficiencies in conducting clinical research at Ochsner.
• Ensures management of HRPP staff and IRB panels for timely and efficient review of submitted studies including managing volunteer members.
• Ensures timely communication with all stakeholders (via emails, periodic newsletters, and other reports).
• Ensures financial stability; manages, develops, retains, and inspires an engaged workforce; and supports technology infrastructure and system improvement.
• Supports development through special projects.
• Performs other related duties as assigned.

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills.

Other duties may be added, or this description amended at any time.

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. The employer is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Physical and Environmental Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Sedentary Work - Exerting up to 10 pounds of force occasionally (Occasionally : activity or condition exists up to 1 / 3 of the time) and / or a negligible amount of force frequently (Frequently : activity or condition exists from 1 / 3 to 2 / 3 of the time) to lift, carry, push, pull, or otherwise move objects.

Sedentary work involves sitting most of the time but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Normal routine involves no exposure to blood, body fluid or tissue and as part of their employment, incumbents are not called upon to perform or assist in emergency care or first aid.

The incumbent has no occupational risk for exposure to communicable diseases.

Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and / or disposal of contaminated waste.

The risk level of exposure may increase depending on the essential job duties of the role.

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Employee Core Benefits Package Includes : Medical coverage Dental coverage Vision coverage Life insurance & Accidental Death and Dismemberment (AD&D) Short-term and long-term disability Retirement plan Paid-time off (vacation / sick / personal days) / paid holidays Paid parental leave *Benefits are subject to change at any time