Job Purpose Wayne State University's (WSU) Division of Research Office of Research Integrity is responsible for ensuring that WSU's Human Research Protection Program comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. The Director, HRPP will oversee the development and implementation of best policies and processes in support of strategies for the regulatory portion of our Human Research Protection Program with a focus on the office(s) responsible for the review and regulatory management of studies involving human subjects and institutional review boards. This position will report to the Assistant Vice President, Human Research Protection Program (HRPP). There will also be a reporting relationship with the Associate Vice President for Research Integrity.
Essential Functions Provide leadership and manage the University's HRPP.
Implement processes to enable the Institutional Review Board (IRB) to function efficiently and ensure issues are effectively addressed.
Oversee processes and preparation for AAHRPP and other accreditations.
Oversee management staff of the IRBs which means to recruit, hire, train, direct daily activities, and develop staff to ensure quality customer service and regulatory compliance.
Ensure that activities of the academic and non-academic staff within the assigned units are performed in compliance with University policies and procedures.
Work with senior leadership to coordinate and establish best practice for management of all aspects of the IRB and the HRPP.
Direct the development of new policies, guidelines, and standard operating procedures of the IRB. Oversee University-wide workshops, training programs, and on-line modules related to the University's compliance program.
Provide fiscal oversight of the IRB to ensure timely and accurate billing/reporting
MINIMUM QUALIFICATIONS EDUCATION Bachelor's degree Graduation from accredited college or university with a master's or professional degree preferably in the health sciences.
Established subject matter expert with the following experience. Ten or more years of experience with clinical trial operations and management including accreditation of clinical research programs, policy development and/or compliance related components of a Human Research Protection Program at a major research university and/or medical center. Three to five years of supervisory experience related to Human Research Protection Programs involving an academic medical center.
Ten or more years of involvement with Institutional Review Boards.
KNOWLEDGE, SKILLS AND ABILITIES Leadership Skills - Demonstrated leadership ability to influence; build relationships; foster collaboration; acquire and develop talent; and inspire to achieve shared objectives.
Strategic Thinking - Ability to work with executive leadership to establish strategic plans, organizational policies and priorities.
Personal Credibility - Possess high ethical standards. Respect the confidentiality of information or concerns shared by others. Interpret and understand University policies and applicable laws and regulations to ensure personal and unit compliance.
Coalition Building - Ability to establish and lead effective communication and outreach plans with the scientific community, industry, the public, and other stakeholders--maintaining cooperative relationships with groups and key stakeholders to further organizational goals.
Problem Solving Skills - Ability to find solutions to difficult or complex issues through meaningful dialogue, collaboration and/or systems analysis, combined with an understanding of and experience with systems, details, and tactical implementation.
Business Acumen - In-depth knowledge of state and federal regulations and HRPP standards. Communication Skills - Excellent written and verbal communication skills. Ability to write grants competitively in peer review process for facility improvements and new construction. Organizational and Planning Skills - Must be able to multi-task, shift priorities and delegate effectively. Ability to plan for multiple contingencies and be able to implement solutions. Develop strategies to achieve organizational goals.
Customer Focus - Must be dedicated to meeting the expectations and requirements of internal and external customers. Establish and maintain effective relationships with customers and gain their trust and respect. Proactively identify customer issues and quickly and effectively resolves customer concerns.
Multicultural - An awareness of multicultural issues and a broad knowledge of diversity dimensions. The ability to serve and engage others in a multicultural environment.
Interested individuals are required to apply to job posting 043051 at https://jobs.wayne/.edu
Wayne State University is a premier institution of higher education offering more than 350 academic programs through 13 schools and colleges to approximately 28,000 students in metropolitan Detroit. Wayne State University is Michigan’s only urban research university, providing world class education in the real world.