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IRB Administrator (325005)

SAIC-Frederick, Inc.

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Location: Rockville, MD Posted Date: 4/11/2013 Position Type: Full time Job Code: 325005 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management
Clinical Research

Description

PROGRAM DESCRIPTION

The Clinical Monitoring Research Program (CMRP) is responsible for coordinating administrative support functions for the National Institutes of Allergy and Infectious Diseases’ (NIAIDs) Institutional Review Board (IRB) Office within the Division of Clinical Research (DCR).

JOB DESCRIPTION

The IRB Administrator assists with the development, implementation and evaluation of policies and practices related to the conduct of the human subjects research. Reviews documents submitted by Principal Investigators (PIs) and study coordinators for IRB review and extracts relevant information to include in the IRB meeting packets and database. Reviews and makes recommendations and/or changes to research protocol documents. Conducts review of draft meeting minutes, incorporates necessary changes and distributes. Attends IRB meetings and contributes to discussions. Serves as liaison between PIs, case managers, study coordinators, the IRB Chair and end users on IRB-related matters. Serves as a central contact for questions and problems related to IRB submissions, overdue protocols, and submission reviews and responses. Keeps abreast of newly modified regulations that impact research on human subjects through literature searches and training. This position is located in Bethesda, Maryland.

Requirements

BASIC QUALIFICATIONS

- Possession of a Bachelor's degree from an accredited college/university in a field related to health or life sciences, or four (4) years related experience in lieu of degree.

- Foreign degrees must be evaluated for U.S. equivalency.

- In addition to education requirements, a minimum of three (3) years related experience in clinical protocols or human subjects protection.

- Ability to review sections of clinical trial protocols to ensure appropriate guidelines are followed for human subjects protections.

- Ability to communicate effectively, orally and in writing, with technical and non-technical individuals both internally and externally.

- Possesses ability to work independently and utilize effective problem solving techniques to handle allegations, complaints and non-compliance issues.

- Ability to prioritize and multi-task in order to meet the needs of the IRB office.

- Ability to work effectively as part of multi-organizational and multi-disciplinary team.

- Ability to interpret and effectively communicate federal regulations.

- Demonstrated knowledge of clinical trial databases and computer software applications, including Microsoft Office® (i.e., Access, Word and Excel).

- In-depth knowledge of department specific regulatory requirements (i.e., Department of Health and Human Services [DHHS], National Institutes of Health [NIH], the U.S. Food and Drug Administration [FDA], IRB, and Good Clinical Practices [GCP]).

- Possesses general knowledge of biological principles, scientific methods and medical terminology.

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

PREFERRED QUALIFICATIONS

- Clinical research, medical laboratory, nursing and/or allied health experience is preferred.

- Knowledge of IRB processes and/or familiarity with clinical research is preferred.

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