Ochsner Health-posted about 2 months ago
Full-time • Mid Level
New Orleans, LA
5,001-10,000 employees

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, sponsors, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Independently organizes and manages all patient care requirements of the company. Serves as an escalation point for junior level departmental staff for problem resolution and support, and typically coordinates trials that are the most complex and/or the greatest number of trials. 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.

  • Participates in clinical trial selection with research leadership and evaluates competing strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
  • Uses the nursing process to ensure protocol compliance including but not limited to patient recruitment, engaging in informed consent, patient education, & oversight of investigational drug administration schedule.
  • 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 PI and monitors patients for safety and adverse events during medical procedures, including administration of parenteral investigational agents depending on area of assignment and with appropriate training and certification.
  • Coordinates special projects related to workflow optimization, periodically reviews, and provides constructive feedback on standard operating procedures and communicates clinical information and work with stakeholders to create best practice tools.
  • Provides mentorship, professional development, and support to less senior team members and interns and assists in precepting new hires and working with leadership to ensure inter-departmental communication and timely departmental onboarding.
  • 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 and serves as a resource for data entry to junior team members.
  • Actively participates in the department’s quality improvement efforts, identifies opportunities for quality improvement to colleagues and management, provides leadership to the research team ensuring collection of source data and documentation that validated integrity of research, and assesses quality assurance of study visits and data.
  • Identifies ongoing professional development needs and seeks resources and opportunities to meet those needs (nursing organizations, independent classes, lectures, etc.)
  • 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.
  • 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.
  • Associate degree in nursing.
  • 5 years of experience in area of assigned clinical specialty including 3 years performing clinical research, or 4 years of relevant research experience in a clinical setting with ACRP, SOCRA, or relevant professional nursing certification.
  • Current registered nurse (RN) license in state of practice.
  • Basic Life Support (BLS) from the American Heart Association.
  • Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
  • Expert understanding of ICH guidelines for ethical conduct of research.
  • Ability to follow and provide critical feedback on the investigational plan.
  • Familiarity with and understanding of lean management principles.
  • Ability to mentor junior staff members on the requirements and regulations associated with the conduct of clinical trials and other related research activities.
  • Ability to interpret and carry out all aspects of a protocol including patient eligibility, assessing adverse events and dose modifications, treatment plan, associated required tests and procedures, and all other aspects of the protocol as required.
  • Expertise in using computers and web-based applications including working knowledge of Epic (Super-Users).
  • Strong foundation with respect to regulatory processes and requirements for all phases of research.
  • Strong interpersonal and leadership skills and ability to mentor junior staff members on the requirements and regulations associated with the conduct of clinical trials and other related research activity.
  • Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts, shifts depending on area of assignment.
  • Bachelor's or degree in nursing
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