Clinical Studies RN III, Cardiology

JOB SUMMARY

Provides specialized nursing care/treatment to a specific group of patients who are participating in clinical research studies within the Cardiology Department.  Functions as part of a research team that may consist of Investigators, Clinical Studies Coordinators, Data Managers, Regulatory Coordinators, and other Nursing Staff. Under the direction of the Investigator, the Clinical Research Nurse III is responsible for subject recruitment, eligibility, enrollment, informed consent, retention, education, and protocol adherence. Provides direction and may mentor other Research Nurses or other support members. Supervises Clinical Research Coordinator(s) as assigned by the Cardiology Research Manager.  Clinical responsibilities include monitoring for adverse events while ensuring the protocol is conducted in a high-quality manner. Conducts clinical research in compliance with GCP, Advocate Health IRB Policies and Procedures, and State, and Federal guidelines. In addition, communicates research-related information to patients, families, nursing, and medical staff as necessary. Cross trains to support the other Clinical Studies Nurses or Clinical Studies Coordinators as needed.  

EDUCATION/EXPERIENCE

• Bachelor's degree in Nursing from an accredited School of Nursing with three years' nursing experience, preferably in a related field, research, acute care, or a specialty area.
• Two years of clinical research experience required (related graduate degree may substitute for one year of experience).
• Master's degree in Nursing with one-year experience in clinical research preferred.

LICENSURE, CERTIFICATION, and/or REGISTRATION

• Licensure as a Registered Nurse (RN) in the State of North Carolina required.
• Must complete the CITI certification for Human Subject Research if not already completed and any additional required WakeOne training for research coordinators.
• Certified Research Professional via SoCRA/ACRP preferred.

ESSENTIAL FUNCTIONS

1. Works under the direction/supervision of the Study Investigators, Disease Team Chair, and the Clinical Research Nurse Manager.
2. Also works in conjunction and with minimal supervision from the Nurse Team Leader to manage assigned clinical trials.
3. Knowledge and understanding of policies, procedures, and regulations governing human subject's research incorporates them in the conduct of research and care of participants.
4. Actively screens patients for protocol enrollment, utilizing knowledge of nursing to review pathology, laboratory results, scans and physician notes to verify patient eligibility.
5. Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants.
6. Coordinates patient schedules and provides information for a successful visit to meet the required protocol procedures, data collection time points and nursing care.
7. Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies.
8. Serves as a nursing expert of specialized patient care, including direct patient care, assessment, documentation, treatment intervention and patient/family education and support in accordance with education/experience, established policies and procedures, and state licensure requirements.
9. Works with Cardiology investigators and staff to maximize identification of eligible study patients for recruitment to research protocols either by referrals or from the current pool of clinical patients. Recruits, consents, and enrolls patients onto trials once eligible patients are identified.
10. Tracks new and follow-up patients for eligibility and recruitment:
    1. Enters patient status information into the cancer center database
    2. Records eligibility assessment and outcome
    3. Educates other clinic staff and physicians regarding protocol specific requirements.
11. Follows care of protocol patients while on protocol treatment to include the following:
    1. Coordinates with the physician and clinic staff to assure that all protocol requirements are scheduled and ordered
    2. Reviews EPIC/WakeOne to ensure protocol compliance and appropriate data collection; verify that all appropriate labs and measurements are performed and ordered correctly
    3. Ensures that charts are clearly labeled for the appropriate drug
    4. Assesses and enter the initial adverse event report and serious adverse events into the eIRB system
    5. Follows-up with the assigned regulatory contact to resolve any outstanding reporting requ