Author: Jon Merz
Date: 07-31-08 12:32
AMDEX
8403 Colesville Road, Suite 850, Silver Spring, MD 20910 • 301-588-4000 • Fax: 301-588-8944
Human Subjects Protection Scientist
AMDEX Corporation is seeking professionals with a minimum of a Bachelor's Degree in the Health Sciences and a clinical research background in Frederick, MD. Please review the following description of the program:
Responsibilities:
Provide support to the Army Medical Research and Materiel Command, Office of Research Protections (ORP) for Army and DOD funded research. Responsible for ensuring research is conducted in compliance with Federal (Department of Defense, Army, 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 and advise the ORP. Protocols include investigational drugs (pharmaceuticals and biologics) and medical devices in Phase I, II and III clinical trials, multi-site, 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. Candidates selected will be subject to government security investigation.
Positions are available for both mid level professionals and senior level Subject Matter Experts.
Requirements:
• Minimum Bachelor's Degree in the Health Sciences
• Clinical research background
• Excellent oral and written communication skills
• Working knowledge of MS Office
• Experience with application and interpretation of regulations
• U.S. Citizenship
• Experience working with FDA, OHRP, or university IRB administrative office
How to apply:
Qualified candidates should submit resumes to bginyard@amdexcorp.com. Please indicate Job #CC002/IRB on all correspondence.
EOE. M/F/D/V
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