Research Nurse Specialist

GLC is seeking a Research Nurse Specialist for a full-time federal contract.

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This position is in Translational Biobehavioral and Health Disparities Branch (TBHD) of the NIH Clinical Center (CC), National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS) in Bethesda, Maryland.

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The NIH Clinical Center is the largest hospital in the world totally dedicated to translational clinical research. The hospital maintains a 200-bed inpatient capacity, with 18 outpatient clinics (including 3 day hospitals) to support the intramural research programs of the 17 Institutes and Centers with clinical programs on the NIH Bethesda campus.

Schedule:

40 hours-Monday-Friday between the hours of 7:00am and 5:30pm. Occasional Saturdays are required.

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Assists Investigator and study team with the execution of clinical trials and assures that all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met/exceeded.

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Interviews, screens, and recruits patients for entry onto protocols.

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Obtains informed consent/assent and addresses complex ethical and legal implications of same.

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Oversees compliance to protocol by developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence

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Provides training to clinic staff with regard to Investigator Brochure information, protocol implementation, general and specific data collection and research practices.

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Performs quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.

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Assists with the collection, processing and handling of laboratory samples.

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Conducts educational presentations to nursing units, clinics and other departments.

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Reports data to appropriate regulatory and monitoring agencies.

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Monitors study enrollment goals and initiates strategies to promote enrollment and participant compliance.

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Maintains study subject databases; supervise data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.

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Position Requirements:

- Minimum of an R.N. degree.

- Licensed as a nurse in the State of Maryland.

- A minimum of 1 years’ experience in a clinical research environment.

- Knowledge of environmental safety, including infection control, isolation technique, aseptic technique, and general security.

- Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records.

- Knowledge of federal regulatory requirements pertaining to clinical research.

- Knowledge of Good Clinical Practice (GCP).

- Able to periodically travel “off-site” (off the NIH Bethesda campus) into the community to assist TBHD research team with protocol planning, recruitment, and implementation activities.

Software Skills required:

- Microsoft Outlook

- Microsoft Word

- Microsoft Excel

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Weekly Pay

Paid vacation

Medical Insurance

401K

Paid federal holidays

Paid sick leave

Dental/Vision Insurance

Short/Long Disability Insurance

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