Job 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. 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. 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 - 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. 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, accreditatio #J-18808-Ljbffr

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