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The mission of the MGH Clinical Translational Research Unit Core is to support investigators in the discovery, development, and implementation of promising therapeutics and associated diagnostics for individuals with complex brain disorders affecting cognition, behavior, emotion, sensory and motor functioning, and other diseases as related to the brain. Under the general supervision of the CTRU Core and with additional supervision from the Managing and Operations Directors of the CTRU, the Research Study Nurse Practitioner(NP) is responsible for specific aspects of protocols and policies for research studies of a large group of investigators representing the MGH Martinos Center for Biomedical Imaging and the MGH Departments of Neurology, Psychiatry and Radiology. The successful applicant will practice within the scope of the advanced practice nurse or physician assistant license as defined by the government of Massachusetts.
For purposes of training and oversight for peripheral IV insertion and management the incumbent will similarly receive direction and general supervision from the Director of Nursing for the Translational Clinical Research Center.
• Participates in daily operational activities necessary for a safe patient/staff environment. Knows and adheres to safety precaution techniques for Universal Precautions per Regulatory Standards.
• Coordinates related patient care activities in the outpatient research setting.
• Contributes clinically across all study protocols by performing protocol-mandated initial and follow-up medical histories, physical and neurological examinations and cognitive and behavioral mental status examinations; by reviewing laboratory, radiological and other relevant clinical reports; by evaluating adverse events to ensure subject safety; and other study related procedures as needed.
• With appropriate training and/or certification, performs medical procedures as needed including phlebotomy, IV infusions, IV insertion as well as IV Management (including drawing blood off IV line for PK studies) lumbar punctures and skin punch biopsies.
• Is responsible for data collection and documentation collects, compiles, tabulates, and analyzes data for the principal investigator(s).
• Delivers professional, ethical and appropriate care to all patients according to the research protocol. Evaluates patients’ responses to study protocols.
• Coordinates and implements the research study according to the study protocol.
• Collaborates with the principal investigator (s) and study team on an ongoing basis regarding progress of the study and the continuation or termination of study subjects.
• Collaborates with physicians, study nurses and coordinators in the selection of appropriate research study patients.
• Performs informed consent as applicable per IRB approved research protocols. Obtains all necessary approvals and subject informed consent when permitted by IRB and assesses patient’s continued eligibility for participation on an ongoing basis.
• Adheres to GCP guidelines and to the study protocol.
• Collects vital signs before, during and post study medication administration or infusion, infusion site assessment, patient monitoring for allergic reactions and post infusion care.
• Acts as liaison between patient and other members of the team regarding patient care activities relating to the research protocol. May require travel to research study subject’s home for study visits.
• Informs the PI of all significant medical events in study participants. In cooperation with the PI, Nurse Manager and/or Managing Director as needed, implement appropriate medical interventions for significant findings during the study participant evaluations.
• Works closely with Clinical Research Coordinators and assists with daily research activities as needed.
• Participates in Quality Assurance/Quality control activities. Performs appropriate Quality Control and Preventative Maintenance procedures.
• Attends protocol investigator meetings as necessary.
• Contributes to the development and publication of research findings.
• Responsible for IRB submissions for protocols.• IV therapy skills required.
• Critical care experience preferred.
• Prior LP experience preferred, if no experience willingness to acquire skill a must
• Excellent customer service capabilities required.
• Ability to work well under pressure a must.
• Ability to work with staff of diverse educational and ethnic backgrounds required.
• Strong leadership skills preferred.
Certifications:
Required:
• Preference given to those with prior clinical trials experience, neurology preferred.
Understands and practices Good clinical practices. Knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).
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