Research Compliance Monitor, IRB

Research Compliance Monitor, IRB

We are searching for an experienced Research Compliance Monitor, IRB at our Detroit campus location.

Wayne State University is a premier, public, urban research university located in the heart of Detroit 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 preparing students for success in a diverse, global society.

Essential Functions:

Position Purpose:

Conduct post‐approval research monitoring visits to observe and document research conduct and regulatory compliance. Submit monitoring reports to the Human Research Protection Program Administration and to the Institutional Review Boards for evaluation and determination of further action. Reports to Associate Vice President, Research.

Essential Job Duties:

Conduct independent post‐approval monitoring visits of human participant research protocols, review protocol regulatory documents, informed consent process and data collection. Generate and update research protocol monitoring lists. Coordinate and schedule post approval monitoring visits and, as needed, follow‐up visits.

Maintain post approval monitoring report files, communicate findings and deficiencies directly to the Principal Investigator, Human Research Protection Program Administration and Institutional Review Boards when appropriate.

Conduct audit activities to identify adverse events and protocol violations and direct to committee Chair, individual Institutional Review Board, institutional officials and/or regulatory agencies as appropriate. Provide procedural guidance to investigators when adverse events or violations are minor, to ensure policy and regulatory compliance are maintained. Conduct For‐Cause Audits as requested by the Institutional Review Board Committee or Human Research Protection Program Administration. Conduct For‐Cause Audit of human participant research protocols, review protocol regulatory documents, informed consent process and data collection. Communicate For‐Cause Audit findings and deficiencies directly to the Principal Investigator, Human Research Protection Program administration and Institutional Review Boards when appropriate.

Maintain and update post approval monitoring policies and procedures. Develop and provide post approval monitoring education sessions for researchers.

Engage with university and affiliate research departments to ensure compliance with federal regulations and institutional policies. When appropriate, in instances concerning research grants, the Administrator will work with the Sponsored Programs Administration to verify concurrence with the grant proposal.

Perform other related duties as assigned.

Qualifications:

Bachelor’s degree from an accredited college or university in a discipline related to business, medicine, public

health, biomedical, life science or basic science. An equivalent combination of education and experience may

be accepted.

Experience:

Requires 2 or more years of experience in a human participant research related job function.

Basic monitoring or audit experience, and biomedical or pharmaceutical research experience preferred.

Knowledge, Skills and Abilities:

Ability to manage a comprehensive monitoring program.

Ability to work independently with minimal supervision.

Ability to analyze and articulate complex issues, including scientific and ethical issues.

Ability to communicate effectively with researchers and colleagues, verbally and in writing.

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

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

Ability to engage researchers and colleagues in a respectful manner.

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

School/College/Division:

H09 - Research

Primary Department:

H0955 - Human & Animal Research Compliance

Employment Type:

Regular Employee

Job Type:

Full Time

Job Category:

Staff/Administrative

Compensation Type:

Annual Salary

Salary Minimum:

$46,927

Salary Hire Maximum:

$56,315

Working Conditions:

This position is stationed within an office setting but will require local travel within the University and its affiliates to conduct the monitoring and audit visits.

Job Openings:

1

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. WSU encourages applications from women, people of color, and other underrepresented people. Wayne State is an affirmative action/equal opportunity employer.