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
IRB Experience required.
Bachelor's degree in a scientific discipline required.
Certification-eligible - Certified IRB Professional (CIP) or Certified IRB Manager (CIM) or Certified Clinical Research Associate (CCRB)
2 years of related experience as a clinical coordinator or research assistant.
Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRMC review and oversight.
Working knowledge of ethical principles related to participation of humans in research.
Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.
Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices.
Following individual training and guidance, ability to become expert at applying DOD, Army and USAMRMC human subjects' protection regulations, policies and guidelines.
Demonstrated ability to use all components of Microsoft Office and to write clear, precise, detailed, comprehensive and grammatically correct memos and technical reports.
Ability to become proficient in the use of an electronic document management system and protocol information management system.
Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success.
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).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Business Consulting and Services
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