Medasource · 2 hours ago
IRB Coordinator
Medasource is a company focused on research compliance, and they are seeking an IRB Coordinator to oversee the pre-review of human subject study submissions. The role involves ensuring compliance with federal regulations and institutional policies while supporting IRB activities and facilitating communication among stakeholders.
Responsibilities
Work with the Director and Associate Director to apply policies, procedures and regulations related to the conduct of research involving varying risk levels
Serves as backup support for the IRB Committee meetings, subcommittee meetings, with preparing of meeting agendas and materials, taking minutes, and advising IRB members on applicable regulations, policies, and review criteria
Pre-review submissions for appropriateness and levels of involvement of human subjects
Prepares and issue letters of approval or requests for further clarification, consent forms, etc
Interacts extensively with IRB staff and research staff on the proper IRB submission to ensure that reports and submissions fulfill all legal requirements, as well as those for quality and accuracy of information, and that all reports have proper supporting documentation
Ensures compliance, promotes the ethical conduct of research and serves as a backup for the Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC)
Maintains knowledge of changes and implementation of the Institutional Review Board (IRB) policies and procedures related to the conduct of human subject research
Reviews and Process IRB submissions per internal policies and procedures. Monitors database for all IRB related research projects, particularly with regard to annual reports
Represents IRB in a professional manner to other health system employees and organizational units
Qualification
Required
Bachelors Degree Required
2 Years Experience working in a research setting with IRB knowledge and experience
Strong interpersonal and communication skills and the ability to work collaboratively and effectively with a wide range of stakeholders
Working knowledge of scientific and medical concepts and terminology
Project a high degree of intelligence, energy, and imagination, and have an outstanding work ethic and personal enthusiasm for the mission, as well as a genuine commitment to the advancement of science and education
Value the importance of equity, diversity, and inclusion as an organizational operating principle
Preferred
Clinical background preferred
Certified Institutional Review Board (IRB) Professional (CIP) - Public Responsibility in Medicine and Research (PRIM&R) Preferred
Certified Clinical Research Coordinator (CCRC®) - Association of Clinical Research Professionals (ACRP) Preferred