Associate Clinical Research Regulatory Coord

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 manages and coordinates all aspects of the clinical trials for selected departments and populations according to regulatory and institutional guidelines and requirements in collaboration with research management and the Principal Investigator and under the supervision of a senior team member. Coordinates and conducts the implementation of all research trials to comply with federal and institutional requirements.

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 - High school diploma or equivalent.

Work Experience

Required - 1 year of relevant research experience in a clinical setting,

OR

a bachelor's degree in life science or related field.

Knowledge Skills and Abilities (KSAs)

• Knowledge of medical and clinical research terminology and processes.
• Knowledge of safe protocol management in clinical trials.
• Ability to coordinate and oversee the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
• Proficiency in using computers, software, and web-based applications including working
• Knowledge of Epic.

Job Duties

• Manages research activities associated with clinical trials and data management under the supervision of a senior staff member and facilitates successful study start-up.
• Maintains study compliance, ensures compliance with regulatory guidelines, and submits protocols and amendments to IRB on behalf of sponsors.
• Participates in internal and external audits.
• Prepares and organizes essential documents.
• Completes status reporting and enters data.
• Seeks opportunities for individual and departmental continuing education.
• 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