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This is a Part-time, .8 FTE, 32 hours a week, hourly/non-exempt, and benefits eligible position.
Minimum pay: $26.19 per hour
The Clinical Research Nurse's (CRN) primary responsibility is to work with the study physician to ensure that all patients involved in a clinical research trial are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring patient care is not compromised while participating in a clinical research trial. The CRN manages all elements of a clinical research trial in order to meet all protocol obligations while following federal regulations; Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures.
The Clinical Research Nurse (CRN) prescribes, delegates, supervises and provides patient care, plans for education, collaborates on care plans and provides for patient safety and quality while the patient is involved in the clinical research trial. In addition, the CRN performs all research activities and procedures as outlined in the protocol; implementing and organizing each clinical research trial they are assigned to, to ensure all federal, state and institutional compliance are followed as well as implementing the trial in the most beneficial way for the patient and their family. Demonstrates nursing competencies to provide age-appropriate care to patients from the age of birth through 21 years, and select adult patients while maintaining the integrity of each clinical trial protocol and patient safety while enrolled in a clinical trial.
Responsibilities:1. Creates clinical trial source documents to ensure all elements of clinical trial protocol are captured at protocol required time points; comparing source documents created to protocol, informed consent document and sponsor provided case report forms or database to ensure accuracy and completeness.2. Provides input into the feasibility of a clinical trial; barriers to subject recruitment and budgetary needs to ensure a successful clinical trial. Attends institutional required feasibility meetings and sponsor required site assessment and study initiation visits. May also travel to sponsor required study protocol meetings.3. Uses nursing process, evidence based practice and unit specific competencies to:a. Identify those patients who meet clinical trial eligibility criteria; ensuring all inclusion criteria are met and no exclusion criteria are present by thorough medical record review, back-up documentation from outside service providers and other means necessary to ensure eligibilityb. Conducts informed consent discussion with patient and family outlining study purpose, risks and potential benefits as well as a thorough discussion of all trial required procedures and visits; answers questions related to study participation as applicable; acts as a patient/family advocatec. Responsible for scheduling, completing procedures and collecting data associated with all protocol required visits in the inpatient, outpatient and community setting.4. Documents a plan of care including patient outcome parameters throughout clinical trial participation including but not limited to: a. Works with study physician and other ancillary service providers to ensure all protocol required procedures are done on time, exactly as indicated in clinical trial protocol and that all data components are captured to ensure compliance with protocol and regulationsb. Evaluates patient care and patient?s response/progress; collect and document all adverse event information throughout trial participation and report to sponsor and Institutional Review Board as requiredc. Reassesses patients and revise plan of care as appropriate; collaborates with study physician to determine when a patient should be withdrawn from a clinical trial due to non-compliance or safety concernsd. Supervises patient care and safety throughout clinical trial participatione. Plan, provide, delegate, and evaluate patient/family education related to the study medication and clinical trial. 5. Collaborates effectively and communicates patient care needs/expectations/priorities related to clinical trial participation to all involved care providers including unit nursing staff, attending physician, ancillary service providers (radiology, cardiology, physical therapy, pharmacy, etc.) to facilitate positive patient outcomes both in clinical care and in clinical trial participation.6. Completes all protocol required procedures including but not limited to venipuncture, IV start, medication administration, EKG?s and all other nursing procedures and assessments.7. Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as required by protocol. Performs CLIA waived laboratory assessments. Obtain and maintain IATA certificate.8. Responsible for managing all data elements associated with clinical trial implementation, execution and close out. Ensures all data elements are collected at protocol required time points; lab, diagnostic reports requiring medical interpretation are reviewed and signed off by an investigator in accordance with all applicable regulations; documentation about clinical trial participation is maintained in each subjects research record in an organized way; completes Case Report Forms (CRFs) prior to monitor visits as instructed by the sponsor; archives all clinical trial related documentation once study close out visit has occurred.9. Works with study physician to provide and document initial clinical trial training for all study team members and ancillary service providers; initiates and maintains documentation for all subsequent protocol required training due to amendments, risk changes, visit procedure changes etc. 10. Responsible for management of regulatory/IRB issues after a clinical trial has been initiated; maintains regulatory binder in conjunction with the regulatory coordinator office.11. Schedules, prepares study data for, and attends monitor visits, audits, or other meetings as required for the study. Works with Research Compliance when audited by sponsor, FDA, DEA or other governmental agency; attends audit meetings and works with regulatory, compliance and study team to respond to audit findings. 12. Participates in and adheres to departmental quality improvement initiatives to maximize quality data collection and compliant study conduct; peer review QA of all consent and inclusion/exclusion visit documentation; protocol implementation checklist; monthly study metric reporting; provides input into unit policy development and revisions and Standard Operating Procedures (SOP).13. Participates in unit maintenance activities as well as Patient Care Services and Hospital activities: a. Safety Huddles within 24 hours of a safety event; Zero Hero initiativesb. Infection control activities c. Joint Commission readiness14. Participates in educational activities in one or more of the following: a. Peer review b. Serves as a preceptor/clinical research resource c. Orientation and continuing education d. Clinical research competency development and assessment e. Planning and presenting classes and presentations internally and at national conferences.15. Adheres to unit/department budgetary standards; keeps weekly time sheet and enters time into eTrac to ensure projects are charged for time spent and unit maintains adequate chargeback ratio to meet annual operating budget16. Practices professional nursing in accordance with the ANA Code of Ethics for Nurses. 17. Maintains flexible schedule daily based on study/unit needs; working days, evenings, weekends, longer shifts and overnight as well as on call, as dictated by protocol requirements to ensure visits, procedures and data are collected at protocol required time points so that each clinical trial is in compliance with all appropriate regulations.
1. Licensure: Licensed as a Registered Nurse in the State of Ohio.
2. BSN; Associate degree with commitment to obtain BSN within 5 years of hire.
3. Current CPR certification. Must be willing to obtain and maintain NRP and PALS certification as determined by your manager.
4. Demonstrates proficiency in clinical nursing skills such as venipuncture, IV starts and injections
5. Understanding of medical terminology and clinical trials preferred.
Working knowledge of PCs, word processing, and data management software
Strong verbal, written, interpersonal communication
Initiation, self-motivation, creativity, flexibility
Organizational and detail oriented
Ability to actively participate as a team player
MINIMUM PHYSICAL REQUIREMENTSNote frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit.MINIMUM PHYSICAL REQUIREMENTS:Talking on phone/in person; frequently (34-100%)Sitting; frequently (34-100%)Standing/Walking; frequently (34-100%)Lifts objects weighing up to 25 pounds; occasionally (0-33%)Typing on keyboard; occasionally (0-33%) The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.