Research Nurse Specialist

The Brody School of Department at East Carolina University (ECU) is composed of 18 departments which function to: 1) provide health care for the citizens of eastern North Carolina; 2) educate primary care physicians to meet the health care needs of eastern North Carolina; and 3) make medical education available to minority and disadvantaged people. The Department of Cardiovascular Sciences (herein referred to as Cardiovascular Sciences or CVS) is the university’s newest department, and is a primary contributor to the School’s mission of medical education, patient care, research, and community service.
Playing an important role in the Brody School of Department’s academic group practice, the Department of Cardiovascular Sciences consists of the Department Chairman, two Medical Directors of Clinical Services, four leadership core units (Department Administrator, CVS Operations Committee/Section Chiefs, Nurse Administrator, and Vice Chairman and Director of Research), and seven clinical and educational divisions. The primary roles of education (students, residents, fellows and continuing medical education), clinical services (Structural Heart Disease, Electrophysiology & Arrhythmias, Heart Failure, Primary and Secondary Prevention, and Vascular Diseases), research (clinical and basic bench research in cardiovascular clinical care, clinical trials to develop new treatments for cardiovascular disease, educational programs for local, regional, and national health care providers, and wellness and prevention programs), academic affairs/faculty development, and administration (business and clinical support services) are led by the Department Chairman and CVS Operations Committee. (Please reference organizational chart).
The clinical sections represented in Cardiovascular Diseases include: Structural Heart Disease, Electrophysiology & Arrhythmias, Heart Failure, Primary and Secondary Prevention, and Vascular Diseases. There are currently 40 MD and PhD faculty members, 15 Fellows, and 16 Physician Extenders and Cardiovascular Sciences Technicians.
A clinical, administrative, and research support staff numbering nearly 160 CSS and SPA employees provides support to the Department of Cardiovascular Sciences’ faculty and learner groups. Subspecialty fellows (fully trained internists receiving training in a clinical subspecialty within Cardiovascular Sciences and Internal Department) currently number fifteen.
The majority of the department’s educational, clinical and research activities take place within the context of the East Carolina University Brody School of Department and the University Health Systems of Eastern North Carolina-Pitt County. The central component of the medical center will be the new East Carolina Heart Institute (ECHI). Designed to be a world-class cardiovascular destination offering state-of-the-art medical technology, education, and research in one location, the East Carolina Heart Institute is composed of three main partners: Vidant Medical Center, East Carolina University, and private practice practitioners. The Institute is committed to superior patient care, collaborative research, and continuous training and education. The East Carolina Heart Institute is the umbrella name for the two facilities that make up the Institute.

Present information to research support staff Availability on the patient care units, the catch lab emergency room and outpatient office to evaluate patients for eligibility for current clinical trials. monitors enrollment goals and modify recruitment strategies if necessary. Performs and supervises medical history, medication history, patient demographics, and medical records for screening and or patient participation. Supervise and /or provide explanation of the informed consent to study patients in the absence of the primary investigator. Monitor study team compliance with the required study protocol, signatures of informed consent and good clinical practice standards. Assess and insure subject safety throughout participation in clinical trials. Develop appropriate “study protocol kits” which will facilitate the screening and enrollment process and ensure the collection of correct date necessary for completion of the case report forms. Develop appropriate flow sheets for support staff documentation of study events. Monitor/evaluate report pertinent labs, pathology, EKG, x-ray, monitors and other medical reports maintain weekly status reports and subject logs; schedule and prepare for CRA monitoring visit oversee recording and documenting of protocol deviations. Maintain ongoing communication with the IRB, annual updates, adverse events, protocol amendments/revisions, expedited or full committee review, informed consent modifications, proper submission of IRB processing form for all new protocols. Respond to sponsor queries in a timely manner and document medical events as requested. Prepares adverse event reports and supplies relevant information to aid the investigator in determination of the seriousness of the event and its relationship to drug or device. Ensure the reporting of site related serious and non serious adverse vents to the sponsor and IRB and maintain follow though to the resolution of the event. Report all sponsor sent adverse events to the IRB in a timely manner. Maintain research data for sponsor/FDA required times usually no less than 15 years. Evaluate effort and formulate recommendations at the close of the clinical trial to improve research support staff performance. Prepare for and respond to all sponsor of FDA audits. Knowledge of study design to evaluate the feasibility of the protocol for phased II-IV Type of design (e.g. double blind, placebo controlled, and randomization scheme) Compassionate use Treatment indication if investigational new drug (IND) Devices/ apparatus. Knowledge of regulations regarding: MDA, IND medical devices, review of protocol for clarity, thoroughness, logistic feasibility and maintaining of subject safety and welfare determine subject population availability via patient data base and other appropriate means, personnel required to complete trial facility and equipment.
Position will prepare an initial analysis of proposed research protocols which will include patient demographics, budget review, and feasibility of the study within the ECU and PCMH systems and personal requirements to undertake the study. A patient referral network will be developed along with a patient data base of potential clinical research patients. This position will keep an open line of communication with all referring physicians in writing and by telephone to keep them updated regarding not only their patients and current studies but new clinical trails that will be opening. If necessary, visits will be made to local referring practices and hospitals to educate staff regarding clinical trials involving their offices. Determines anticipated study -related cost and profit margins (e.g. fixed overhead, direct and indirect costs, patient honorariums and IRB tax). Monitors the revenue and expense activity of each clinical trial. Maintain ongoing record of enrollment and follow up on payment schedule with the sponsors/CROs and ECU financial services. Provide and or create appropriate training materials and seminars to adequately instruct nursing and other personnel in research related duties required to conduct clinical trials with excellence, accuracy, detail and integrity of data. Make available research teaching material, manuals and journals pertaining to cardiovascular clinical trails. Update staff regarding status and outcomes of cardiovascular clinical trials closed and currently enrolling. Inform/educate staff about protocols and related procedures. Encourage and foster the participation and cooperation of others in the overall planning and development of research activities. Provide opportunities for in servicing by providing materials, instructions and occasional speakers for the purpose of staff development within the department of cardiology regarding cardiovascular research activities. Orient all clinical trial support staff to the demands of new and current cardiovascular protocols, including co-investigators, fellow, nursing, heart center. Informs and presents verbally and in writing to the principle investigator and all co investigators all the pertinent clinical trials/research related information. Protocol, investigator brochure, and related scientific data: Source documentation: laboratory requirements, procedure requirements, Patient recruitment criteria and time line IRB requirements. FDA regulations, Times of site initiation, monitor and closeout visits and audits. Marketing/networking with sponsors: Prepare marketing materials clinical site brochures, letters of introduction, clinical trial references. Communicate availability and capabilities of this clinical site regarding cardiovascular services. Search for potential referral services. Personal contact and written communication to area physicians and health care providers: Position will provide liaison between the general public, the various departments of the hospital and the physician regarding the availability of cardiovascular research protocols, within the division of cardiology and the development of new technologies at the Cardiovascular center.
Assure patient compliance with the protocol over the course of the trial period (often one to five years) Perform physical assessments as necessary, collect medical history. Obtain informed consent, dispense oral medications, administer IV medications, and assist in performing tests. Determine need for medical intervention necessity based on patient complaints, assessments and /or laboratory data control and document the distribution of study medication. Insure that supplies, lab kits and materials need for study are ordered as needed. Communicate with patient families, nurses and referring physicians and other allied health care personal as needed. Determine the clinical needs of the patient independently and alert the physician if there is a need for adjustments in treatment
Will function as the resource person for all cardiovascular clinical trials. Support the division of cardiology by the teaching of students, residents and other health care personnel in the understanding of research within the cardiovascular department. Assist in the developing of ongoing clinical education for staff by recruiting guest speakers in the field of cardiovascular research. Work closely with the heart center nurse education specialists to develop ongoing clinical educations, for nursing personnel in the field of cardiovascular research. Provide patient teaching which includes instructions to patients and assisting family members in the participation in the patients care. Provide brochures regarding information for the public on what clinical trials are and their importance in improving medical care.

CLINICAL SUPPORT POSITION – NOT SUBJECT TO STATE HUMAN RESOURCES ACT.

The ECU Brody School of Medicine is affiliated with Vidant Medical Center. Vidant Medical Center is the flagship hospital for Vidant Health and serves as the teaching hospital for the Brody School of Medicine at East Carolina University.

Graduation from state-accredited school of registered nursing and two years of nursing experience, with at least one year in the assigned specialty area. Must have a current license to practice as a Registered Nurse in North Carolina by the North Carolina Board of Nursing. All degrees must be received from appropriately accredited institutions.

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East Carolina University is an equal opportunity and affirmative action employer and seeks to create an environment that fosters the recruitment and retention of a more diverse student body, faculty, staff and administration. We encourage qualified applicants from women, minorities, veterans, individuals with a disability, and historically underrepresented groups. All qualified applicants will receive consideration for employment without regard to their race/ethnicity, color, genetic information, national origin, religion, sex, sexual orientation, gender identity, age, disability, political affiliation, or veteran status.

Individuals requesting accommodation under the Americans with Disabilities Act Amendments Act (ADAAA) should contact the Department of Human Resources at (252) 737-1018 (Voice/TTY) or ADA-Coordinator@ecu.edu .

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If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (252) 328-9847 or toll free at 1-866-489-1740 or send an email to employment@ecu.edu. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.