RN Research

About the role

The Research RN, NCHRI works directly with the physician in accurately and professionally executing all clinical research projects in an acute care/inpatient setting (ED, Cath Lab, ICU, EP lab, Step down and OR) as well as the ambulatory and ancillary areas.

Responsibilities

• Oversees clinical research studies, collecting all clinical data in an accurate and timely manner.
• Performs required procedures and data collection activities at necessary in observational settings such as, ED, Cath Lab, EP Lab, ICU/Step down area, physician office, OR, and other required areas.
• Serves as primary clinical contact person for study sponsor, patient, family, and other healthcare contacts/departments.
• Assures all data points are supported by medical records, physician notes, diagnostic reports, procedural summaries, or research project documents.
• Delivers data that is accurate and complete, matching source and data entry information.
• Facilitates physician oversight of all data, especially adverse event reporting as it relates to study drug, device, or therapy.
• Works with sponsor’s auditor/monitor to review and verify accuracy and completeness of data recorded.
• Delivers data within required timelines per sponsor expectations.
• Coordinates critical research tasks and patient activities in accordance with Good Clinical Practice (GCP).
• Serves as the contact for physicians and other caregivers in assuring all research and related clinical needs are met.
• Assists in the initiation and maintenance of accurate protocol processes.
• Verifies that patients are scheduled appropriately for follow up evaluations per protocol.
• Assures patients are well educated as to the importance of compliance with study objectives through ongoing education and reminders.
• Maintains the control of drug/device inventory per log or other acceptable documentation.
• Guides referring physicians in GCP compliance and clinical care through protocol design and awareness through education.
• Makes recommendations on how to facilitate special or acute needs of patients.
• Aids screeners with patient consenting and performs re-consenting when necessary and in accordance with GCP.
• Knows and fulfills IRB/FDA expectations in the execution of these critical tasks.
• Actively participates in any FDA audits that may occur, both in preparation and execution of the process.
• Facilitates and maintains high patient enrollment and participation in research protocols.
• Encourages new patient enrollment, working with physicians and screeners to seek out all efforts to facilitate a successful process.
• Works closely with patient, family, and research staff to assure good patient rapport and high-quality clinical care, re-enforcing the desire for patient’s retention in the trial.
• Alerts Manager and physicians of patient withdrawal or continuance issues quickly in the event they might intervene and prevent withdrawal.
• Participates directly in-patient care duties associated with the project.
• Maintains required skills and clinical knowledge to manage the wide scope of clinical needs.
• Maintains awareness of all research projects so as to serve as a back-up support as needed.
• Provides nursing knowledge and decision-making support to non-RN research team members seeking support.
• Promotes teamwork and seeks to provide high quality care to all patients.
• Serves as a Representative of the NCH Research Institute.
• Performs as a role model to both department and hospital staff, serves as a liaison with physicians and collaborating staff.
• Serves as the primary clinical trial contact person for study sponsor, patient, family, or other healthcare contacts or departments.
• Represents the Research Institute in a professional manner, demonstrating knowledge and enthusiasm for clinical research.
• Serves as an internal and external resource for questions referencing clinical research at NCH.
• Professionally represents Principal Investigator and NCH Research Institute at protocol meetings and conference calls in the absence of the Investigator.

Qualifications

• Minimum of 2 years of experience in Critical Care/Cardiology preferred.
• Licensed as a Registered Nurse (RN) in the State of Florida.
• Basic Life Support (BLS) certification required from the American Red Cross or American Heart Association.
• Strong Communication and Problem-Solving skills and the ability to remain flexible.
• Advanced Life Support (ALS) certification preferred from the American Red Cross or American Heart Association.
• Intermediate computer knowledge: Uses Microsoft Word, Excel, Outlook, and Windows.
• Excellent communication and interpersonal skills.