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Clinical Research Nurse II 324924

SAIC-Frederick, Inc.

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Location: Bethesda, MD Posted Date: 4/12/2013 Position Type: Full time Job Code: 324924 Required Education: Other Areas of Expertise Desired: Clinical Research
Nursing

Description

PROGRAM DESCRIPTION

The Clinical Monitoring Research Program (CMRP) provides clinical research nursing support to the National Institute of Allergy and Infectious Diseases' (NIAIDs) Laboratory of Host Diseases (LHD) within the Division of Clinical Research (DCR).

JOB DESCRIPTION

The Clinical Research Nurse (CRN) II will perform work independently under the general direction of the Protocol Nurse Coordinator III. Serves as liaison between clinical and laboratory personnel and the LHD Principal Investigators (PIs). Participates in clinical trials protocol development: develops procedure manuals for clinical protocols; helps create Case Report Forms; trains staff; and may visit off-site collaborative centers. Advises on and participates in the management and evaluation of multiple clinical protocols. Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations. Interfaces with the Protocol Support Office. The CRN II coordinates various activities to ensure proper and timely filing of Serious Adverse Events, amendments, annual reports and other regulatory documents. Interacts with auditing and monitoring agencies to facilitate the exchange of data. Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved. Monitors and oversees activities pertaining to clinical protocols, including monitoring patient recruitment and retention, trial progress and the need for extension or renewal of ongoing clinical trials. Assures quality and human subjects protection. Assists with writing protocols and protocol amendments to ensure regulatory requirements. Assists PIs in interpreting research data for dissemination to the protocol team. May conduct updates for clinical staff on patient care, protocol process and progress, human subjects protections, International Conference on Harmonization/Good Clinical Practices (ICH/GCP) and quality assurance education. This position is located at the National Institutes of Health (NIH) in Bethesda, Maryland.

Requirements

BASIC QUALIFICATIONS

- Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed.

- Current State license as a registered nurse (RN). Foreign degrees must be evaluated for U.S. equivalency.

- In addition to education requirements, two (2) years clinical research nursing experience.

- Possesses knowledge of clinical research data collection and clinical data report preparation.

- Demonstrated experience in the coordination, implementation and execution of clinical trials.

- Ability to work in a data management setting in the capture and analysis of patient data, including toxicity assessment, drug administration and laboratory results.

- This position is subject to obtaining a Public Trust Clearance.

PREFERRED QUALIFICATIONS

- Prior infectious diseases experience is preferred.

- Experience in a clinical trials outpatient setting and/or experience in data management and collection is preferred.

- Possession of a Bachelor's degree would be a plus

For more information about the Clinical Monitoring Research Program please visit http://cmrp.ncifcrf.gov/CMRP/Default.aspx

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