Human Subjects Research, IRB Protocol, IRB Submission, Research Protocols Certifications:
None Experience:
5 + years of related experience US Citizenship Required:
Yes
Job Description:
Seize your opportunity to make a personal impact as a Senior Human Su bjects Protection Scientist supporting the Office of Research and Regulatory Compliance (ORRC), Office of Human Research Oversight (OHRO) at Defense Health Agency Research & Development (DHA R&D).
HOW YOU WILL MAKE AN IMPACT:
Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, DoD, Food and Drug Administration (FDA), state, host nation, and DHA R&D human subjects protection requirements
Reviewers will be assigned a portfolio of protocols for initial review; this includes determinations of not research, research not involving human subjects, exempt research, non-exempt research, and protocols utilizing cadavers/cadaveric specimens
Provide accurate information, assistance, and documents to customers and OHRO Federal personnel when requested with appropriate professionalism in a timely manner
This will require active management of the assigned protocol portfolio; this includes data entry activities and use of OHRO specific information management systems to track information and activities related to protocol review
Assist in the development of local procedures and guidance for the OHRO and the DHA R&D in the area of human subjects' protection
Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines
Assist in development and implementation of internal OHRO operating procedures and review guidelines as requested
Foster regulatory compliance through education and training of investigators, research managers, administrators, and OHRO staff, and provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements
WHAT YOU'LL NEED TO SUCCEED:
Education: Bachelor's Degree in a scientific, or related discipline
Required Experience: 3+ years of related human subjects' protection experience
Benefits
Health insuranceVision insurance
Additional Information
Type of Requisition:
Regular
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
None
Public Trust/Other Required:
NACI (T1)
Job Family:
Science and Research
Job Qualifications:
General Dynamics It · Fort Detrick, MD