In addition, the Associate Director will manage the protocol review process, identify issues, and determine whether the components of the proposed research are compliant with federal, state, and local regulations, University policies, and accreditation standards.

Essential Functions:

Under the guidance of the Director, HRPP, assist with overall direction of the IRB and implement process improvement initiatives. Develop, implement, and manage efficient and best-practice procedures to facilitate the review process of human research protocols in accordance with WSU policies, federal and state regulations, and accreditation standards. Plan and coordinate IRB review and follow-up activities.

Provide leadership and direction to the IRB Administration staff which includes hiring, performance management, coaching, training, termination, and prepare staffing recommendations for IRB Administration. Develop the staff to ensure accurate and timely customer service and regulatory compliance. Ensure that activities of the academic and non-academic personnel within the IRB unit are performed in compliance with university policy and procedure.

Oversee and manage the IRB database and submission systems (currently eProtocol and Coeus). Coordinate the engagement of the IRB staff and reviewers with eProtocol IRB software. Manage information posted on Wayne State IRB website and listserv.

With guidance from the HRPP Director; manage, prepare and participate in audits (internal, and external regulatory), accreditation (AAHRPP) and their respective site visits.

Serve as an expert liaison between the research investigator and the reviewer; providing education to parties on relevant and emerging regulations and identifying related risk management issues.

Perform review of complex research protocols, including identifying problems and issues in the submission application and work with investigators and their staff to satisfy application requirements and provide compliance support.

Assess programmatic needs and develop business plans for proposed changes. Generate reports of IRB activities to assist with programmatic assessments. Prepare budget, approve expenditures and requisitions.

Perform other related duties as assigned.

Additional Education Information: Bachelor's degree in business or public administration or other relevant discipline, from an accredited college or university. Postgraduate degree preferred.

Experience: Specialist(minimum 5 years of job-related experience)

Additional Experience Information: Minimum 5 years management experience, preferably related to human research protections and compliance. Attainment of Council for Certification of IRB Professionals (CCIP) certification, Applied Research Ethics National Association (ARENA) Certified IRB Professional (CIP) or National Association of IRB Managers Certification in IRB Management (CIM) desired.

Knowledge, Skills and Abilities:

LEADERSHIP SKILLS - Ability to provide direction to staff and committee members. Ability to influence and foster collaboration. Ability to delegate work, set clear direction and manage workflow. Strong mentoring and coaching skills. Ability to train staff and develop subordinate's skills. Ability to foster teamwork among staff members.

PERSONAL CREDIBILITY - Possess high ethical standards. Respect the confidentiality of information or concerns shared by others.

COMMUNICATION SKILLS - Excellent written and verbal communications skills.

INTERPERSONAL SKILLS - Effective interpersonal and customer service skills.

Ability to influence and motivate others. Consultative skills related to process improvement and policy/guideline development and implementation.

CUSTOMER FOCUS - 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 resolve customer concerns.

ORGANIZATIONAL AND PLANNING – Ability to multi-task, shift priorities and delegate effectively. Ability to plan for multiple contingencies and implement effective solutions. Develop strategies to achieve organizational goals. Ability to prepare and present special projects with little or no supervision/oversight. Ability to meet deadlines.

ANALYTICAL SKILLS - Ability to compare, contrast and quality check work with a keen attention to detail. Strong analytical skills including critical thinking, problem solving skills, and generation of budget or other reports. 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.

REGULATORY KNOWLEDGE - Familiarity with regulatory and ethical aspects of human research, including processes and requirements for AAHRPP accreditation.

TECHNOLOGY SKILLS - Proficient in the use of database management systems, Microsoft Office tools.

MULTICULTURAL AWARENESS - An awareness of multicultural issues and a broad knowledge of diversity dimensions. The ability to serve and engage others in a multicultural environment.

ENTERPRISE UNDERSTANDING - In-depth knowledge of University policies, applicable state and federal regulations and AAHRPP accreditation standards. Understand WSU’s strategic plan, mission, vision and the department’s overall goals and objectives.