Description

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 evaluates initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility.
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 Ochsner's discretion.

Education

Required - High School diploma or equivalent

Work Experience

Required - 3 years of relevant research experience in a clinical setting,
OR
2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification.

Certifications

Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.

Knowledge Skills and Abilities (KSAs)

• Must have computer skills and dexterity required for data entry and retrieval of patient information. Must be proficient with Windows-style applications and keyboard.
• Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Must have computer skills and dexterity required for data entry and retrieval of information
• Must be proficient with Windows-style applications, various software packages specific to role and keyboard

Job Duties
• Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
• Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
• Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
• Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
• Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Supports department, division, and institutional goals.

Other related duties as required. 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.

Complies with the Ochsner Health System 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.

Ochsner 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.

Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.

Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.

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.

There is no occupational risk for exposure to communicable diseases.

Are you ready to make a difference? Apply Today!

Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website.

Please refer to the job description to determine whether the position you are interested in is remote or on-site. Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C.

Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at 504-842-4748 (select option 1) or careers@ochsner.org. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.