GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under general supervision of Dr. Herminia Diana Rosas, the Research Study Nurse Practitioner(NP)/Physician Assistant(PA) is responsible for specific aspects of protocols and policies for research studies of Down's syndrome, Huntington's disease and other neurocognitive disorders being conducted in the Center for Neuroimaging of Aging and Neurodegenerative disorders, in addition to assisting in the research conducted in the Center for Aging and Neurodegenerative, within the scope of the advanced practice or physician assistant license as defined by the government of Massachusetts and may serve as Co-I. PRINCIPAL DUTIES AND RESPONSIBILITIES:
Qualifications :SKILLS & COMPETENCIES REQUIRED:
- 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. Sub or Co-I is responsible for data collection and documentation. Collects, compiles, tabulates and analyzes data for the principal investigator(s).
- 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; by following up with study participant between in person visits; by obtaining medication history;and other study related procedures as needed.
- 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.
- Performs required procedures, including blood draws, as well as collection of other relevant samples..
- 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.
- 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 protocols.
- With appropriate training and/or certification, performs medical procedures as needed including phlebotomy, IV infusions, IV insertion as well as IV Management, lumbar punctures and skin punch biopsies, as needed.
- 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, implements appropriate medical interventions for significant findings during the study participant evaluations.
- 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.
- Contributes to IRB submissions for protocols, including initial submissions, amendments, continuing review and reporting of adverse events.
- IV therapy skills required.
- Critical care experience preferred.
- Prior LP experience preferred; if no experience willingness to acquire skill a plus.
- Excellent customer service capabilities required.
- Ability to work well under pressure a must.
- Ability to multi-task and work on various protocols a must.
- Ability to work with staff of diverse educational and ethnic backgrounds required.
- Strong leadership skills preferred.
- Prior Clinical Trial experience required. Minimum of 3-5 years 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). LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:Licenses Required:
Valid MA NP or PA LicenseCertifications Required:
Current, valid NP or PARegistrations Required:
MSCR EDUCATION: Minimum Required:
Doctoral Degree EXPERIENCE: Required:
Prior nursing/PA experience with an ability to perform IV infusions. SUPERVISORY RESPONSIBILITY (authority to hire, promote, or terminate):
Indirect: Oversight of junior CRC's. WORKING CONDITIONS:
Charlestown Navy Yard, MGH Main Campus and Charles River Plaza, 165 Cambridge Street, Boston
Occasional home visits may be needed.
Position dependent on continued NIH funding.