Description:
The Clinical Research Nurse will be responsible for rendering patient care services to patients on research protocols approved through the local IRB. Major roles include those of practitioner, researcher, educator and consultant demonstrating skills in the following areas: specific disease management nursing, data management, physical assessment skills, leadership ability and communication skills.
Responsibilities involve:
Patient registration
Data collection
Data submission
Adverse event reporting
Patient follow-up
Records management
Protocol regulatory management
Quality assurance
Other related research tasks
PRIMARY DUTIES AND RESPONSIBILITIES:
Coordinates, and performs, clinical procedures during research visits (i.e. vital signs, blood draws, EKGs, drug administration, and other clinical activities as necessary and capable) in conjunction with appropriate training/certification and following hospital policy. Assists clinical staff responsible for research patient visits complete the research requirements
Review and verify subject eligibility based on study inclusion/exclusion criteria
Identify, recruit and screen potential clinical study participants
Obtain informed consent from patients in coordination with the Investigator
Leads the clinical research team in the identification, evaluation and reporting of all adverse events and severe adverse events
Support the team in obtaining, and disseminating, accurate clinical information essential for completing Case Report Forms (CRF)
Synthesize clinical knowledge with protocol requirements to foster informed, protocol compliant, decision-making in the best interest of patient safety and in coordination with the investigator. Modifies treatment s per protocol
Assure that all federal, state, local, and hospital laws and regulations are adhered to, as they relate to the protection of human subjects and to research compliance
Provide backup coverage for other CRNs studies when necessary (travel to other sites may be required)
Facilitate industry sponsored pre-study / initiation visits and provides sponsor monitor with required site information
Secure patient records and source documentation for sponsor monitoring and internal/external site audits
Obtains, and maintains, database access. Enters data as needed
Practices proper safety techniques in accordance with hospital and departmental policies and procedures and immediately reports any mechanical or electrical equipment malfunctions, unsafe conditions, or employee, patient, visitor injury or accident to the assigned Manager
Skills:
Clinical research, Oncology, inpatient, Gcp, Irb, Data management, BLS, CPR, AED, Registered Nurse, communication and leadership skills, CCRC or CCRP Certified, patient registration, quality assurance, subject eligibility, EMR, clinical trial, regulatory, oncology nursing, chart review, enrollment, adverse event reporting
Top Skills Details:
Clinical Research, Oncology, Inpatient, CP, IRB, Data Management, BLS, CPR, AED, Registered Nurse
Additional Skills & Qualifications:
REQUIRED: (Will have to show proof of certs to pass compliance)
Graduate of an accredited school of nursing with a Bachelor or Associate degree and current and unencumbered licensure as a Registered Nurse in the State of Georgia
One (1) year relevant work experience in a clinical setting
Current and valid American Heart Association Basic Life Support (BLS) Provider CPR & AED Program card
If not Certified Clinical Research Coordinator (CCRC) or a Certified Clinical Research Professional (CCRP) at time of hire, must achieve professional certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) within three (3) years of hire.
If not certified at time of hire, must obtain within three (3) years of hire: Oncology Certified Nurse (OCN) through the Oncology Nursing Certification Corporation (ONCC)
Experience Level:
Intermediate Level
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