Institutional Review Board (IRB) Administrator
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Job Location:
Mequon, WI - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Concordia University is a Lutheran higher education community committed to helping students develop in mind body and spirit for service to Christ in the Church and in the world.
Position Summary
The IRB Administrator serves as CUWAAs Institutional Review Board (IRB) primary contact. The role will be positioned within the Office of Research and Sponsored Programs and can be based at our Mequon WI campus or our Ann Arbor MI campus. Remote employees will also be considered.
Job Duties & Responsibilities
- Primary IRB contact: Ensure compliance with 45 CFR 46 OHRP guidance and CUWAA policies.
- Protocol intake and pre-review: Conduct administrative pre-reviews; determine review category (Exempt Expedited Full Board); flag when Limited IRB Review applies.
- Committee operations: Coordinate meetings; manage agendas quorum reviewer assignments; prepare compliant minutes; maintain IRB roster and member training records (CITI).
- Records management: Maintain approvals determinations deferrals correspondence and adverse event/unanticipated problem reports in accordance with retention requirements.
- Investigator support: Advise on applications; consent/assent/waiver language; recruitment materials; data security/FERPA/HIPAA considerations; specimen/data use.
- Training compliance: Administer and verify CITI/RCR completion; maintain centralized training logs linked to protocol personnel.
- Platform administration: Administer the eIRB system (Cayuse) including workflows forms templates permissions user support and quality control.
- Post-approval monitoring: Conduct routine and for-cause monitoring; coordinate responses to noncompliance or reportable events.
- Policy/Standard Operating Procedure (SOP) maintenance: Assist with updates to IRB SOPs and related research integrity policies to align with current federal standards.
- Professional development: Organize and deliver professional development to faculty and students.
- Other duties as assigned
Knowledge Skills & Abilities
- Able to Collaborate closely with the IRB Chair and members ORSP pre- and post-award staff Finance Legal/Compliance IT/Data Security and academic units.
- Regulatory knowledge: Strong familiarity with 45 CFR 46 (Common Rule).
- Systems: Experience administering or using Cayuse IRB strongly preferred.
- Excellent communication and customer service for advising faculty/students
- Strong organization attention to detail and recordkeeping
- Discretion with confidential/sensitive information; sound judgment
- Training/outreach capability for faculty and student investigators
- Supportive of the mission and values of Concordia University Wisconsin/Ann Arbor and the Lutheran Church Missouri Synod (LCMS)
Education & Experience
- Education: Bachelors degree required; advanced degree (masters or higher) preferred.
- Experience: 3-5 years of demonstrated experience with IRB processes.
Physical Demands/Equipment (Click to View)
Compensation & Benefits
This is a part-time (<29.5 hours per week) non-exempt position. Starting wage may be determined upon education and/or experience. Benefits associated with this position include the Concordia Disability and Survivor plan and the Concordia Retirement plan as well as a tuition waiver benefit.
Application Instructions
To receive full consideration all applicants are asked to complete and submit an online employment application through the Concordia University Employment page. To begin please click the Apply Now section on the job page and then click the Apply For This Position button to begin the application process.
Equal Opportunity Employer
It is the policy of CU to provide equal opportunity to all employees and applicants for employment in accordance with all applicable federal state and local laws.
The University will not discriminate against or harass any employee or applicant for employment because of race color sex pregnancy national origin (including ancestry) citizenship status physical or mental disability age marital status gender veteran or military status predisposing genetic characteristics domestic violence victim status or any other characteristic protected by federal state or local laws.
However CU is an institution of the LCMS and to the extent allowed by law CU reserves the right to give preference in employment based on addition preference in holding certain employment positions is given to ordained or rostered ministers of the LCMS. Based on a religious tenet CU recognizes only male LCMS ordained Ministers of the Gospel but recognizes both male and female LCMS Rostered Ministers of the Gospel.
The Human Resources Department has been appointed to manage the equal employment opportunity program including all equal employment opportunity activities as required by federal state and local agencies. If any employee or applicant for employment believes this policy has been violated he/she must contact the Director of Human Resources.
Concordia University is a HLC accredited co-educational liberal arts school offering more than 72 undergraduate majors over 35 masters degree programs and 5 doctoral programs. There are also a variety of accelerated evening and e-learning programs.
Required Experience:
Unclear Seniority
Key Skills
- Time Management
- Diplomatic Skills
- Risk Management
- Influencing Skills
- Organizational Skill
- Accounting & Finance
- Strategy Management
- People Management
- Industril Knowledge
- Communication
- Negotiation Skills
- Strategic Thinking Skills
- Leadership Skill
- Problem Solving Skills
- Regulatory&Governance
About Company
Concordia University Wisconsin is a 4-year, NCA-accredited, co-educational, liberal arts school offering undergraduate, graduate, online, and international programs.
