External IRB Reviewer, Division of Research

External IRB Reviewer, Division of Research

Wayne State University is searching for an experiencedExternal IRB Reviewer, Division of Researchat 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.

Position Purpose:

The External Institutional Review Board (IRB) Reviewer will manage the IRB Reliance requests via the External IRB Review Process comprised of addressing administrative reviews and management of multi-center research oversight. This position will collaborate with the Wayne State university (WSU) research community and external IRBs to facilitate the external review process, provide guidance as it relates to the External IRB Process, and will support the IRB Administration by providing internal quality assurance measures and data management. This position will report to the Director, Human Research Protection Program.

Essential Functions:

Serve as the WSU IRB External IRB Reliance Reviewer and Single IRB Multisite Pre-Reviewer to determine completeness and compliance with all applicable regulations and institutional polices. The External IRBs and Single IRB Multisite Pre-Reviewer include institutional IRBs, commercial IRBs, the National Cancer Institute Central IRB (NCI-CIRB), and applicable IRBs. Reviews and processes revisions for External and Single IRB multistate submissions. Facilitates the establishment of the single IRB and external review for WSU research.

Serve as the subject matter expert to researchers, IRB members, staff and study coordinators regarding the interpretation and application of research regulations, Federal and State regulations, and policies and procedures governing the participation of human participants in research.

Collaborate with researchers and IRB members to address any deficiencies or concerns identified during the review process. Share best practices through effective communication and teaching skills, to assist investigators and their staff to anticipate ethical issues and to address these issues in their submissions. Evaluate the risks and benefits associated with research studies and make recommendations for their improvement. Effectively communicate issues raised by the IRB or Investigators to the Human Research Protection Program (HRPP) Director and IRB Associate Director.

Prepare for internal and external audits. Keep up to date on the latest regulations, guidelines, and ethical standards related to human subject research.

Review and provide feedback on IRB forms, manuals, policies, procedures, and standard operating practices. Assist with the training and mentoring of new IRB Reviewers and staff members.

Performs other related duties as assigned.

Minimum Qualifications:

Education : Bachelor's degree

Bachelor's degree in a relevant field such as law, medicine, public health, biomedical or basic science is preferred.

Post-Baccalaureate degree preferred

Experience : Experienced (minimum 2 years of job-related experience)

At least 2 years of experience working as an IRB reviewer or in a related role.

Knowledge of research regulations as they pertain to the conduct of human participant research

KNOWLEDGE, SKILLS, AND ABILITIES:

Proficient computer skills including knowledge of Microsoft Office Suite and familiarity with electronic IRB submission systems.

Strong organizational and analytical skills with the ability to critically evaluate research protocols, identify potential ethical concerns, and manage a comprehensive monitoring program.

Ability to effectively communicate verbally and in writing with researchers and colleagues. Knowledge of Federal and State research regulations.

Ability to collaborate with researchers, IRB members, and stakeholders in a respectful manner.

Ability to maintain privacy and confidentiality as they pertain to research and monitoring activity.

Attention to detail and ability to prioritize tasks to meet deadlines in a fast-paced environment.

Ability to work independently with minimal supervision.

Skilled in the use of computers and software such as Microsoft Office, Microsoft Outlook, and institutional specific software.

School/College/Division:

H09 - Research

Primary department:

H0955 - Human & Animal Research Compliance

Employment type:

• Regular Employee

• Job type: Full Time

• Job category: Staff/Administrative

Funding/salary information:

• Compensation type: Annual Salary

• Annual Salary: To be determined

Working conditions:

Normal office environment.

This position is located within an office setting in the Institutional Review Board offices.

This position must be filled pursuant to the provisions of a collective bargaining agreement, and as such may be filled by a qualified bargaining unit member, should one apply.

Job openings:

• Number of openings: 1

• Reposted position: No

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.