Director of Human Research Protection Program
The Director of Human Research Protections Program (HRPP) at the Medical College of Wisconsin is responsible for the overall administration of the program for protecting human subjects/participants in research, including the oversight and implementation of, and compliance with, institutional policies and procedures, federal and state statutes and regulations, and ethical and professional standards for the conduct of human research. The Director will work closely with Unit Leadership, Principal investigators, and Institutional Review Board (IRB) chairs. There are six IRB committees currently.
For fiscal year 2018, MCW had 559 active clinical trials and 135 new clinical trial approvals. The organization also functions as the IRB of record for all human subject research engaged in by faculty, staff or trainees at Froedtert Health System and Versiti Blood Research Institute.
Desired Educational & Skill Requirements:
• MD, PhD or other terminal degree with 7 years’ experience, ideally in a relevant academic, healthcare, government or industry research enterprise with direct experience in regulatory compliance and/or research subject protections.
• 5+ years of direct supervisory/management experience. Previous leadership experience combined with a proven and demonstrated track record of leading others and achieving outstanding results.
• In-depth knowledge of the numerous issues impacting the review, approval, and monitoring of clinical and non-clinical research involving human subjects
• Background and knowledge of the regulatory environment for Human Subjects Protections, and ability to maintain contacts with other similar entities to ensure that the Human Research Protections Program is aligned with national standards.
• Qualifications to hold a faculty appointment. Candidate will be offered an Assistant Dean role with appropriate faculty appointment.
• Excellent communication skills and a commitment to superb customer service for the internal and external leadership, stakeholders, and team members.
• Expertise and experience in supervision and oversight of Internal Review Boards (IRBs) at an Academic Medical Center
• Ability to analyze a situation and provide a solution that is innovative and efficient.
• Diplomacy and problem-solving skills, motivating and able to productively supervise a diverse group of staff
• Ability to work collaboratively with the IRB Chairs, Institutional Official and Office of Research leadership to facilitate on-going development, implementation, and maintenance of the HRPP.
• Ability to work collegially with other units, within MCW, supporting the HRPP, such as Legal, Compliance, clinical affiliate partners, and clinical research units
Interested candidates should submit CV to Lee Moran, Senior Executive Consultant, email@example.com.