Description
**Overview**
The Clinical Research Nurse (CRN) works with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the CommonSpirit Health Research Institute. The incumbent has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise. S/he serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of practice. In conjunction with the PI and other facility/clinic staff, s/he may provide direct patient care related to a research protocol.
The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent works with the MCRM to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as CommonSpirit Health policy.
This position is responsible for maintaining quality standards for responsive service and professional documentation in compliance with CommonSpirit Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of CommonSpirit Health. This is an exempt position that may require occasional overnight travel and weekend assignments.
**Responsibilities**
**(45%) Division/Site Research Operations**
Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i. e., NIH Stroke Scale, NYHA and CCS class.
Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of practice.
Report change in research participant condition to PI and appropriate personnel in a timely manner.
Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy.
In conjunction with the PI and other facility/clinic staff, may provide direct patient care related to the research protocol.
Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or CommonSpirit Health.
Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements
Attend investigator/coordinator meetings as required by study sponsors
Coordinate and participate in site initiation and other sponsor-required training for all protocols.
Serve as liaison between participants, physician investigators, sponsors of research, IRBs, CSHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
(35%) Quality Assurance / Performance Improvement
With minimal guidance, implement clinical trials and research projects that meet CommonSpirit Health Research Institute (CSHRI) and facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U. S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, as well as CSHRI requirements.
Work with CSHRI billing staff to ensure clinical trials are performed in accordance with CommonSpirit Health requirements; complete Research Encounter Forms for all participant visits.
General Duties (20%)
Serve as clinical nursing knowledge role model in the care of research participants.
Assist Market Clinical Research Manager (MCRM), PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site; provide recommendations. Complete clinical portions of sponsors' feasibility questionnaires.
Obtain PI signatures on all required study documents.
Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to CommonSpirit Health's Code of Conduct
Complete professional and clinical education annual
Compensation Information:
$0.0 / - $0.0 /
Starting At: 0.0
Up To: 0.0
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