Director, Human Research Protection Program, Division of Research

Wayne State University, United States

Updated: 3 months ago
Location: Detroit, MICHIGAN

Wayne State University is searching for an experienced Director, Human Research Protection Program, Division of Research at its Detroit campus location.

Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society.


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 Associate Vice President for Research Integrity. 

ESSENTIAL FUNCTIONS:

Provide leadership and manage the University’s HRPP (Human Research Protection Program).

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 (Association for the Accreditation of Human Research Protection Programs).

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 (Institutional Review Board) and the HRPP. (Human Research Protection Program).

Direct the development of new policies, guidelines, and standard operating procedures of the IRB(Institutional Review Board). 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.

Other duties as assigned.


MINIMUM QUALIFICATIONS:

Education:    Bachelor’s degree               

Graduation from accredited college or university with a master's or professional degree preferably in the health sciences.

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

Established subject matter expert with the following experience.

10 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.

3 to 5 years of supervisory experience related to Human Research Protection Programs involving an academic medical center.

10 or more years of involvement with Institutional Review Boards.

KNOWLEDGE SKILLS & 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 resolve 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.


SCHOOL/COLLEGE/DIVISION:

H09 - Research


PRIMARY DEPARTMENT:

H0905 - VP Research


EMPLOYMENT TYPE:
  • Regular Employee
  • Job type: Full Time
  • Job category: Staff/Administrative

FUNDING/SALARY INFORMATION:
  • Compensation type: Annual Salary
  • Salary :  To be determined

WORKING CONDITIONS:

Normal office environment.


JOB OPENINGS:
BACKGROUND CHECK REQUIREMENTS:

University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required.


EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Wayne State University provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. The university encourages applications from women, people of color and other underrepresented people. Wayne State is an affirmative action/equal opportunity employer.


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