Clinical Research Coordinator

About the role

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. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company. Coordinates trials that are more complex and/or a greater number of trials than the associate level.

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 - 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)

• Knowledge of medical and clinical research terminology and processes.
• Working knowledge of ICH guidelines for ethical conduct of research.
• Strong critical thinking skills.
• Ability to follow and provide critical feedback on the investigational plan
• Ability to develop study related budgets, contracts, and patient consent documents.
• Working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Proficiency in using computers, software, and web-based applications, including working knowledge of Epic.
• 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 organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques.
• Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts.

Job Duties

• Organizes strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
• Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI).
• Serves as primary point of contact for patient to report and triage adverse events and independently conducts informed consent.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment.
• Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies.
• Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
• Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems.
• Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
• Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
• Performs other related duties as assigned.

Additional information

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.

Physical and Environmental Demands

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.

Duties performed routinely require exposure to blood, body fluid and tissue.

The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all 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.

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.

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