The Director, Human Research Protections (HRPP) supports the Drexel research community in the conduct of ethical research by providing direction, execution, and regulatory oversight to all core components of the institution's HRPP including Institutional Review Board, Research Compliance Training, and Quality Assurance and Improvement. The Director serves as the primary contact for HRPP regarding human research protection issues for the institution. The Director has responsibility for the institutions distributed program for protecting human participants in research. The Director should have comprehensive knowledge of all aspects of the institution system of protections for research participants, as well as be familiar with the institutions commitments under the Federal wide Assurance (FWA) for the Protection of Human Subjects and play a key role in ensuring that the organization fulfills its responsibilities under the FWA.
Essential Functions
Management - Demonstrated experience supervising human subjects research compliance remotely and through virtual means as necessary, including virtual board meetings, remote staff monitoring, and training.
Regulations, Policy, and Guidance - Demonstrated experience applying NIH, FDA, DoD, and other regulatory requirements governing human subject research and AAHRPP standards and accreditation requirements. Knowledge of HIPAA regulations and state laws governing privacy. Working knowledge of scientific and medical concepts, terminology, and clinical care procedures and standards. Working knowledge of good clinical/research practices and standards.
Compliance and Reporting - Work closely with institutional leadership to ensure compliance with the ethical and regulatory requirements for human subjects’ research. Apply federal, state, and local regulations, policies and procedures related to research involving human participants. Act as liaison with federal and state agencies on human research issues. Develop and manage a quality assurance program for both the research community and the IRB to support routine monitoring and for-cause auditing in a virtual environment.
Education and Outreach - Maintain a current knowledge of federal/state laws/regulations, institution policies and guidelines governing human subject research, participate in and provide education and training. Identify educational needs of researchers based on audit data and other information. Lead the development and delivery of targeted training programs and materials based on IRB review and audit results and/or changes to legislative, statutory, and institution requirements.
Quality Improvement - Demonstrated work experience in implementing large scale quality improvement projects, and electronic system implementation.
Required Qualifications
Bachelor’s Degree
A minimum of 5 years of experience
Other requirements
Management experience
Degree requirements may be substituted with an equivalent combination of education, training and experience managing human subjects research projects
Must obtain Certified IRB Professional (CIP) credential within first year of employment
Preferred Qualifications
Certified IRB Professional (CIP) or Certified IRB Manager (CIM), Master's degree in health sciences.
Drexel University is an Equal Opportunity/Affirmative Action employer, welcomes individuals from diverse backgrounds and perspectives, and believes that an inclusive and respectful environment enriches the University community and the educational and employment experience of its members. The University prohibits discrimination against individuals on the basis of race, color, national origin, religion, sex, sexual orientation, disability, age, status as a veteran or special disabled veteran, gender identity or expression, genetic information, pregnancy, childbirth or related medical conditions and any other prohibited characteristic.
