What are the responsibilities and job description for the Senior Human Subjects Protection Scientist position at CICONIX, LLC?
CICONIX is seeking a Senior Human Subjects Protection Scientist to join our team supporting the U.S. Army Medical Research and Development Command (MRDC) Office of Research Protections.
· A comprehensive pre-review of research protocols and supporting documents before review by a convened IRB or via expedited review procedure
· Post-IRB approval lifecycle management of assigned research protocols, including pre-review of amendments, continuation reports, reports of unanticipated problems/serious adverse events/serious or continuing noncompliance/ research suspension or termination /protocol deviations, and final study reports
· Support for site visits (monitoring, non-compliance) to include preparation and planning visits, assisting during visits, and preparing written reports
· Assistance in the development and updating of the IRBs human subjects protection policies, procedures, guidelines, and process improvement initiatives
· Assistance in developing human subjects protection education and training programs
· Assistance in the IRB's internal quality control/assurance program
· Support for the Human Research Protections Office, as needed, to include conducting DoD-required reviews for USAMRDC-supported research and DoD-conducted research. The individual will work on Ft. Detrick as a member of a team comprised of military, government civil service and contract employees.
REQUIRED QUALIFICATIONS:
· Bachelor's Degree in Science, Public Health or related discipline
· 5 years direct human subjects research experience supporting either an IRB office or regulatory office
· Current training in humans subjects protection.
· Ability to quickly become proficient in use of an on-line document management system and an Oracle-based protocol information management system
· Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices
· Proficient in use of Microsoft Word, Outlook, and Excel
· US Citizenship and NACI Clearable
CICONIX, LLC is an Equal Opportunity Employer
· Competitive market-based salary, commensurate with experience and education
· Comprehensive benefits package available (Medical, Dental, Vision PTO, 401k).
