Associate Clinical Research Regulatory Coord

Ochsner Health; New Orleans (LA); On-site; USD 55,000 - 75,000; Full time

Job summary

Ochsner Health in New Orleans is seeking a Clinical Trials Coordinator to manage all aspects of selected department trials in line with regulatory requirements and PI collaboration.

The role requires a high school diploma or equivalent with 1 year of research experience or a life-science degree; duties include start-up, documentation, audits, data entry, and Epic software usage to support compliant study conduct.

Qualifications

• Experience with clinical trial processes and regulatory requirements.
• Familiarity with IRB submissions and study start-up processes.
• Ability to coordinate with Principal Investigator and regulatory teams.

Responsibilities

• Coordinate and manage clinical trial activities across departments.
• Maintain regulatory compliance and prepare for internal/external audits.
• Prepare essential documents and study-related submissions.
• Support study startup, ongoing data management, and reporting.
• Submit protocols and amendments to IRB on behalf of sponsors.
• Assist in data entry and maintain accurate study records.

Skills

Medical research terminology

Protocol management

Regulatory coordination

Epic software

Data entry/management

Education

Bachelor's degree in life science or related field

High school diploma or equivalent

Tools

Epic

Job description

Exceptional care starts with exceptional people. For us, this is more than a job- it's a calling. It's waking up each day, looking for ways to make a difference with a compassionate, inclusive and talented team. Ochsner empowers you to discover your passion, reach your potential, and Pursue Your Purpose. Exceptional care starts with exceptional people and teams. Together we are leading the way.

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

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.

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.