| Human Subjects Protection Scientist – Clinical -- Frederick, MD |
Author: Jon Merz
Date: 02-04-10 15:44
Human Subjects Protection Scientist – Clinical (C002/PRM)
Location: Frederick, MD
AMDEX Corporation is seeking professionals with a minimum of a Bachelor's Degree in Nursing with an emphasis on critical care and/or trauma care. Candidates with clinical research experience are especially encouraged to apply.
Responsibilities
* Provide support for DoD funded research. Responsible for ensuring research is conducted in compliance with Federal (DoD, HHS, FDA) laws, regulations, policies and guidelines, and that the rights and safety of human subjects involved in the research are protected.
* Review and evaluate exempt, minimal risk and greater than minimal risk human research protocols, consent forms, supporting documents, study amendments, adverse event reports, and continuing review reports. Protocols include investigational drugs (pharmaceuticals and biologics) and medical devices in Phase I, II and III clinical trails, multisite international studies and a wide variety of human research submitted by military research facilities, academia and industry. Will also provide guidance for developing protocols.
* Assist Institutional Review Boards (IRBs) and investigators with obtaining DoD Assurance Agreements. Participate in planning, execution, and preparation of reports for staff assistance visits designed to educate personnel, observe operations, and audit IRB and investigator study records. Develop policies and procedures relating to the protection of human subjects.
* Positions are available for both mid-level professionals and senior level Subject Matter Experts.
Qualifications
* Minimum Bachelor's Degree in Nursing
* Clinical research background
* Excellent oral and written communication skills
* Working knowledge of MS Office
* Experience with application and interpretation of regulations
* U.S. Citizenship (Candidates selected will be subject to government security investigation.)
* Experience working with FDA, OHRP, or university IRB administrative office
* Strong analytical skills
* Experience as a critical care nurse or experience in trauma care is desired
Qualified candidates should submit resumes to rbaliff@amdexcorp.com. Please indicate job code CC002/PRM on all correspondence.
AMDEX Corporation offers a competitive salary package and attractive benefits package. Please visit our website at www.amdexcorp.com.
EOE M/F/D/V
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Author |
Date |
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Human Subjects Protection Scientist – Clinical -- Frederick, MD |
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Jon Merz |
02-04-10 15:44 |
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