What are the responsibilities and job description for the Human Subjects Protection Scientist II 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:
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).
