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 Associate Director, Research Compliance and Regulatory Affairs will provide oversight and expertise for the design, implementation, and ongoing monitoring of an effective compliance program for human subjects research at the Institute. In addition, this position will be responsible for providing regulatory advice on a day-to-day basis with respect to applicable federal and state laws and regulations and institutional policies, the collection and use of biospecimens, biosafety, and animal care and use. This position will interact extensively with faculty researchers at the Institute and relevant personnel of the Johns Hopkins University School of Medicine, including the Office of Human Subjects Research and Institutional Review Boards (IRB).
Design, implement, and oversee a compliance plan for all human subjects research at the Institute.
Support in the interpretation of regulatory requirements and provide appropriate guidance on issues, concerns, and/or risks associated with human and animal research in collaboration with the Director,Research Administration and legal counsel.
Supervise Office of Human Research Administration staff.
Provide to Executive leadership detailed critical reports of compliance findings and proposed corrective action plans, trend analyses, and policy and training proposals.
Review and respond to adverse events, protocol deviations, and unanticipated problems to ensure appropriate and timely reporting.
Oversee internal compliance activities, including the performance of routine monitoring visits and for-cause audits of human subjects research studies. Provide regulatory guidance to the Institute’s High Risk Research Committee.
Provide consultation to clinical research staff as needed in preparation for external audits conducted by study sponsors, federal agencies, or other designated review groups.
Keep apprised of and provide guidance on current industry-standard regulatory and compliance issues and trends.
Maintain thorough institutional documentation, records, and databases related to compliance and regulatory functions.
Collaborate with team members to draft new and/or revise existing institutional policies and procedures related to research compliance.
Liaise with relevant internal departments including Clinical Trials Unit, Office of Research Programs, and Corporate Compliance, as well as relevant personnel of the Johns Hopkins University School of Medicine and other external universities and partners.
Relevant certification(s) such as Certified in Healthcare Research Compliance (CHRC)® preferred.
Juris Doctor (J.D.) from an accredited law school required.
Minimum of 5 years of research compliance and/or regulatory affairs experience at an active academic health center, university, or government agency required.
Will also consider candidates with relevant health law experience.
Internal Number: 5606
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.