Company: Akahi Services
Posted on: January 10, 2021
Academic/Faculty/Research opening in Bethesda, Maryland. This
and other rn jobs brought to you by NursingJobCafe.com Research
NurseAkahi Associates, LLC is seeking a highly qualified Research
Nurse to work at our client site the National Human Genome Research
Institute of Health in Bethesda, MD. This is a full-time position
with benefits. 40 hours per week, Monday – Friday.TASKS/SERVICES.
The contractor shall:
- Provide support for clinical studies, including FDA-regulated
clinical trials related to GNE myopathy.
- Provide daily updates to Leadership, study coordination staff,
and the clinical team on IC study patient admittance to the NIH
- Enter protocol orders.
- Schedule, plan, and coordinate study visits and
protocol-related evaluations with patients, evaluators, and
- Collect and ship clinical laboratory samples as described in
- Identify adverse events and notify Leadership.
- Monitor drug compliance by subjects throughout the life of the
protocol; document missed doses.
- Participate in discharge planning; coordinate referral to
community agencies; coordinate care with community providers.
- Provide patient/family support.
- Work with Leadership and protocol coordinator throughout the
life cycle of the protocol.
- Review and understand the protocol study procedures, timelines,
inclusion and exclusion criteria, confidentiality, and privacy
- Assist in the recruitment and retention of patients into
clinical protocols; maintain enrollment log.
- Coordinate and organize the educational aspects of studies to
provide optimal participation, compliance, and minimize protocol
- Assist Leadership in communicating study requirements to all
individuals involved in the studies.
- Monitor protocol compliance and adherence, including completion
of evaluations and follow-up visits within the window required by
the protocol, to minimize protocol deviations.
- Communicate with members of the team, including evaluators,
consultants, laboratory, pharmacy, and nursing staff to ensure
timely completion of all protocol-related evaluations and study
- Inform patients on study diary, study drug administration, and
other study requirements.
- Complete source documents (data collection).
- Maintain data integrity and retrieval and interpret needs for
principal investigators, patients, and other staff.
- Implement the standards for research protocols in compliance
with regulatory, institutional and external agencies.
- Participate in training/orientation program geared toward the
Principles of Clinical Trials.
- Attend and participate in regularly scheduled clinical rounds
and conferences.DELIVERABLES. Upon request, the contractor shall
provide documentation evidence of any and/or all work product,
including, but not limited to, the following tasks:
- Work products and documents related to providing high-quality,
timely patient care to clinical study participants.
- Work products and documents related to contacting and
following-up with study participants.
- Work products and documents related to performing daily
clinical team rounds.· Work products and documents related to
performing all patient-related evaluations.CERTIFICATIONS, LICENSE,
PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. The contractor
- Master's degree in nursing. Three (3) years of specialized
experience plus a BA/BS degree is equivalent to a Master's degree.
Current state nursing license
- Minimum of two (2) years of nursing experience with CPR
certification. Experience in clinical research setting with
protocols and clinical trials.
- Work collaboratively in a multi-disciplinary team of
- ·Excellent analytical, organizational, verbal and written
communication, and time management skills.
- Knowledge of maintaining accurate and detailed records.
- Rare disease interest or previous experience.
- Thorough knowledge of the regulations and guidance that govern
the clinical trial process, including ICH Good Clinical Practices
and FDA regulations.For further information, please click to view
the EEO Is The Law poster. Qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, sexual orientation, gender
identity, disability or protected veteran status. Only qualified
individuals who are being considered will be contacted for an
interview. Keyphrases: medical faculty jobs, medical research jobs,
biostatistics faculty jobs
Keywords: Akahi Services, Bethesda , Research Nurse, Healthcare , Bethesda, Maryland
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