Clinical Trial Risk Based Monitoring Jobs in Louisiana

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 Industry-Sponsored, NCI-Sponsored 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 participant's 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 Sponsor's 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 high-quality 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 job-relevant 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 (Bachelor's 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 multi-tasking 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