| Continuing Review Analyst -- Frederick, MD |
Author: Jon Merz
Date: 07-02-10 19:15
Continuing Review Analyst
Location: Frederick, MD
AMDEX Corporation is seeking motivated, detail-oriented individuals with human subjects protection in research regulatory review experience to provide support to the US Army Medical Research and Materiel Command (USAMRMC), Office of Research Protection (ORP), and Human Research Protection Office (HRPO) for funded research. Assignment location is Fort Detrick in Frederick, Maryland.
Responsibilities
* Use the tracking capability of the ORP HRPO Information Management System (IMS) to monitor the status of Continuing Review Reports that are due, actions taken to issue reminders when they are due, when they are received, and the completeness of the reports received. If submittals are incomplete, reflect the actions taken to ensure compliance.
* In coordination with the ORP HRPO, identify the lead time to send reminders in advance of when Continuing Review Reports should be received and send reminders to the protocol Principal Investigator of the due dates for receipt of Continuing Reviews.
* Examine Continuing Review Reports received for compliance with human subjects protection regulations. Identify any issues associated with the post approval conduct of studies. Coordinate with the assigned Human Subjects Protection Scientist to complete the reviews and pass the reports for proper filing and updating of the tracking database. If it is determined the reviewed Continuing Review Reports are incomplete, work with principal investigators on complete submissions. Assist in the development of office SOPs and policies as they relate to continuing review processes and post approval compliance monitoring.
Qualifications
* Bachelor's Degree
* Excellent oral and written communication skills
* Working knowledge of MS Office and experience using an IMS relational database
* Detail oriented with excellent organizational skills and the ability to multi-task
* Experience with application and interpretation of human subjects protection regulations
* U.S. Citizenship
* Ability to successfully pass a Background Investigation
Qualified candidates should submit resumes to jwilberding@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
Brief description about AMDEX Corporation:
AMDEX endeavors, on a daily basis, to improve the health and well-being of our nation through the meaningful connection of information technology. AMDEX has been at the forefront of interoperable IT solutions since our inception in 1987. We have grown today to become one of the premier providers of innovative IT solutions to the Federal Government.
Our fundamental work – in the domains of Health IT (HIT), information technology, IT Security, Web Technologies, and Knowledge Management for organizations as diverse as the National Institutes of Health (NIH), the Department of Defense, the Department of Health and Human Services, and the Department of Homeland Security – reflect our commitment to our Federal government and its stakeholders to “improve the health and well-being of every American through the meaningful delivery of (health) information technology services.”
AMDEX Corporation exists to service the technological health of our nation and, in turn, nurture the well-being of its citizenry. We believe that by enhancing and advancing America’s “HIT”, we improve ourselves, help shape better communities, and, ultimately, contribute to the prosperity of our great country.
Our AMDEX employee base comes from rich academic, technical, and health oriented backgrounds that allow us to integrate and connect leading edge research and new technologies with our real dedication to the advancement of today’s HIT.
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Continuing Review Analyst -- Frederick, MD new |
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Jon Merz |
07-02-10 19:15 |
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