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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.

Education

Required - Associate degree in nursing.

Preferred - Bachelor's or degree in nursing

Work Experience
Required - 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.

Certifications

Required - Current registered nurse (RN) license in state of practice.

Basic Life Support (BLS) from the American Heart Association.

Knowledge Skills and Abilities (KSAs)

• 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.

Job Duties

• 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.

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.

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.

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.

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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, Maine, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C.

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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.