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The Clinical Research Nurse RN under the guidance and supervision of the Principal Investigator (PI) ensures that the integrity and quality of clinical trials are maintained and conducted in accordance with federal state and local regulations Institutional Review Board (IRB) approvals and FMOLHS policies and procedures. The research nurse will coordinate manage and assist physicians in enrolling assessing and monitoring patients on IndustrySponsored NCISponsored and/or Investigator Initiated clinical trials offered.
1.
Providing Nursing Care to Research Study Participants
Participates in recruitment and selection of study participants in conjunction with treating physician by conducting a thorough review of participants medical history
Informs educates and consents clinical research patients regarding clinical trial participation potential investigational treatment plan and general study participant requirements
Ensures compliance with study protocols by providing thorough patient assessment and documentation at each study visit
Performs procedures according to study protocols (including but not limited to venipuncture EKG study Investigational Product (IP) administration)
Collection processing storage and shipment of patient specimens (blood sputum tissue etc. as directed by study protocols)
Submission of appropriate reports as required by IRB Sponsor or any research entity
Working in collaboration with research pharmacist(s) to ensure proper inventory of IP is maintained at all times
Disburses IP and provides patient teaching regarding IP administration as necessary
Communicates and collaborates with study team including internal and external parties sponsors PI and study participants
2.
Quality
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods practices and procedures for research activities
Provides accurate and timely data collection documentation entry and reporting in Sponsors electronic data capture systems
Ensures compliance with research protocols by providing ongoing quality control audits
Maintains current training including Good Clinical Practice IATA/Dangerous Goods Handling and study specific training as required by sponsors
Utilizes all equipment supplies facilities and resources in a prudent and efficient manner to ensure efficient departmental operations and the provision of highquality health care services
Promotes the quality and efficiency of his/her own performance by remaining current with the latest trends in field of expertise through participation in jobrelevant seminars and workshops attendance at professional conferences and affiliations with national and state professional organizations
3.
Collaboration and Partnership
Manages relationships with study sponsors investigators and associated staff to provide the highest level of performance
Collaborate and meet in person and virtually with study monitors/auditors to ensure study data quality
Attends and participates in committees meetings and programs as required to meet requirements/standards of FMOLHS accreditation organizations
Works to develop the clinical research department by marketing the services of the department to physicians conducting research within FMOLHS and in the private practice setting
Maintains communication with administrative staff for pertinent research opportunities that may become problematic for FMOLHS structures (standards ERDs policies and procedures etc.)
Experience:
Two years as a Clinical Registered Nurse (Bachelors degree may be substituted for one year of work experience). One year of clinical research experience preferred.
Education:
BSN or RN
Special Skills:
Detail Oriented
Ability to proactively identify and solve problems
Strong communication skills with patients physicians and team members
Professional demeanor
Ability to work independently and in a team environment
Strong interpersonal customer service and multitasking skills
Proficiency in Microsoft Office Word and Excel Electronic Health Systems and databases and/or have a willingness to learn and demonstrate proficiency within six months of hire
Work well under pressure and manage deadlines
Licensure
Current unencumbered Registered Nurse license in the state of Louisiana
Full Time