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This job supervises and coordinates all aspects of clinical research trials and studies. Maintains accurate, complete and timely case report forms, assesses patient's eligibility for protocol participation, and monitors therapy and ongoing adverse effects for study patients. Directs and assists licensed and ancillary team members with their assigned responsibilities and coordinates the daily operations of assigned clinical departments in collaboration with leadership. Plans and organizes clinical functions including staffing, staff development, staff evaluation, leadership, and equipment and materials resourcing. Coordinates implementation of disease management systems under the direction of research leadership and physicians.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.
Work Experience
Required - 4 years of experience as a clinical research nurse in clinical trials including 2 years of relevant leadership experience.
3 years of experience as a registered nurse (RN) in a clinical setting.
Experience in assessing adverse effects from investigational drugs or devices.
Certifications
Registered nurse (RN) license in the state of practice.
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.
A certification accredited by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) within 1 year of hire.
Knowledge Skills and Abilities (KSAs)
Proficiency in using computers, software, and web-based applications, including Epic and electronic data capture.
Basic knowledge of Microsoft Word, Excel, data entry and basic statistics.
Effective verbal and written communication skills and ability to develop and present proposals clearly and professionally.
Effective leadership, organizational, decision making and delegation skills.
Excellent interpersonal and customer service skills.
Basic knowledge of federal regulatory requirements.
Excellent organizational, time management and prioritization skills and ability to pay close attention to detail.
Proficiency with standard concepts, procedures and practices of specialty field.
Ability to work a flexible work schedule (e.g. 24/7, weekend, holiday, on call availability) and travel throughout and between facilities.
Job Duties
Meets with industry monitors and sponsors and acts as a liaison between the organization and our industry sponsors to assure quality of study conduct.
Provides protocol support and guidance to research staff and aides in interpretation and execution of protocols where necessary.
Assists with troubleshooting daily issues related to staffing, equipment, study-related insurance authorizations and electronic systems where possible and identifies appropriate contacts where necessary.
Works with leadership to develop efficient systems allowing for cost-effective utilization of nurse skills and helps ensure that workload is properly distributed between different clinical research staff groups.
Supervises, develops and retains an engaged workforce.
Assists with research, education & training to support cutting edge patient care and services.
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 required.
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.
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.
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. There may be an 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.
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.
Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C.
Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at 504-842-4748 (select option 1) or careers@ochsner.org. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
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.