Coordinates patient procedures for cardiac cath, interventional and EP testing, coordinates chart prep for procedures working with NEHI Cardiologists to complete order required for procedures. Ensures effective delivery of clinical patient care and compliance of administrative and clinical policies and procedures. Directs implements and actively participates in diverse clinical research trials in support of the clinical research endeavors of the New England Heart Institute. Collects cardiovascular clinical data. Analyzes and validates clinical research outcomes and reports these findings within established guidelines to appropriate regulatory boards.
DUTIES AND RESPONSIBILITIES
Under the direct supervision of the Practice Administrator, NEHI and within established Catholic Medical Center departmental policies and procedures, the incumbent performs the following functions:
Reviews procedural booking to confirm procedures booked according to clinical order and chart notes.
Requires prioritization of multiple projects, activities and assignments.
Ensures all clinical orders have been completed testing, anticoagulation, medication and procedural orders.
Provides patients with instructions prior to procedure and ensures all tests and labs have been ordered.
Coordinates with cath & ep lab arrival times for patients
Actively recruits appropriate patient populations for specific research protocols.
Conducts educational in-services and provides ongoing clinical and educational support necessary departments to ensure appropriate clinical care is delivered safely and in compliance with the research protocol. Directs the implementation of cardiovascular inpatient and outpatient clinical research trials.
Collaborates with primary research investigators to prepare Institutional Review Board (IRB) documents. Attends all investigator research meetings as required by the research sponsor.
Collaborates with the study sponsor or their representative ensuring each study is conducted in accordance with the Clinical Protocol.
Complies with all US FDA Good Clinical Practice regulations including those regulations for Institutional Review Board, Informed Consent, and regulations for The Protection of Human Subjects.
Ensures associates, patients and staff are informed of study obligations. Provides clinical updates promptly when indicated.
Maintains confidential study records on all patients. Marks the medical record indicating the patient is participating in Clinical Research. Does not destroy any study record without written sponsor consent.
Maintains and retains adequate and accurate study records. Makes all study records and source documents available for audits. Retains all study documents as required by the FDA/Study Sponsor.
Ensures that no conflicting study trials are competing for patients and resources. Updates the regulatory binder in compliance with good clinical research practice
Communicates with each study patient’s primary care physician and sends appropriate clinical updates and laboratory results regularly.
Accurately dispenses study medication adhering to the research protocol. Maintains accurate records of all drugs supplied.
Promptly notifies the Principle Investigator and primary care physician of any clinically significant adverse event that jeopardized the participant’s life or safety. Notifies the study sponsor within 24 hours of any serious or clinically significant adverse events. Promptly notifies the IRB of any clinically significant or serious adverse events.
Informs the patient/IRB of any relevant information which becomes available during the clinical trial.
Education: Graduate of an accredited school of nursing.
Experience: Three (3) years of medical-surgical and one (1) year Of clinical experience in a critical care/telemetry Unit environment, including cardiac diagnostic & Interventional patient mix. Data collection, Validation and research experience preferred. Ability to utilize and support an integrated EMR.
Licensure/Certification: Currently licensed in the State of New Hampshire as a
Registered Nurse. BCLS and ACLS certified. BSN required.