PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
the Regulatory Affairs Specialist will be responsible for providing regulatory advice on a day-to-day basis to the Office of Human Research Administration with respect to applicable federal, state, and local laws, regulations, and regulatory practice relating to protection of human subjects in research and compliance with applicable research regulations. This position will interact extensively with the Johns Hopkins School of Medicine IRB as well as other external IRBs when appropriate.
Develops and implements policies and procedures to support the compliant conduct of research at Kennedy Krieger Institute, in consultation with the Director.
Interprets and applies all aspects of pertinent federal and state regulations pertaining to human subjects research.
Previews documents submitted with IRB applications and works with faculty and research staff to identify deficiencies under federal and state laws and regulations and Kennedy Krieger policies to be corrected prior to IRB review.
Determines that appropriate protocol-specific documentation is submitted with requests for waiver of consent, waiver of HIPAA authorizations, and additional required HIPAA forms.
Serves as the lead contact and policy expert for the research community and IRBs external to KKI regarding KKI policies and procedures related to Human Subjects research.
Oversees applications and handles all government interactions pertaining to the regulation process for products requiring governmental approval.
Consults on regulatory processes, risk assessment, and ethics evaluation for industry-sponsored clinical trials.
Assists on other projects as needed.
J.D. from an accredited law school required.
Bachelor’s degree in related discipline (i.e., allied health profession, social sciences, nursing) from accredited 4-year college.
Minimum of 3 years of experience relevant to the planning, conducting or administration of human studies highly desirable.
Experience in group process and dynamics is preferred.
Internal Number: 3550
About Kennedy Krieger Institute
Located in Baltimore, MD, Kennedy Krieger Institute is an internationally recognized institution dedicated to improving the lives of children and young adults with pediatric developmental disabilities and disorders of the brain, spinal cord and musculoskeletal system, through patient care, special education, research, and professional training.