The posting
Summary
Work independently under the direction of the Quality Assurance Manager and/or Program Director to coordinate and oversee Institutional Review Board (IRB) activities for Center for International Blood & Marrow Transplant Research (CIBMTR) research database protocols. Manage regulatory processes to ensure compliance with Human Research Protection Program (HRPP) requirements, institutional policies, and applicable federal regulations governing human subjects research. Serve as a subject matter resource for IRB-related activities across a large network of participating research centers and facilitate timely protocol review, approval, and maintenance activities.
Primary Responsibilities
- Serve as the CIBMTR MCW primary coordinator for all IRB activities associated with assigned research database protocols.
- Manage Annual Continuing Progress Reviews (CPRs), ensuring timely submissions, approvals, and follow-up actions.
- Coordinate protocol amendments, revisions, renewals, and closures.
- Serve as liaison for all IRB communications between CIBMTR, MCW and participating research centers.
- Monitor site-specific IRB approval status, expiration dates, and documentation requirements for more than 200 participating sites.
- Develop and maintain systems for tracking protocol approval status, site participation, and regulatory milestones.
- Monitor utilization of the NMDP Central IRB and identify sites utilizing alternative IRB review processes.
- Work with participating centers to understand and document local IRB review pathways and approval requirements.
- Collaborate with Research Database Protocol team and participating sites to ensure ongoing compliance with protocol and regulatory requirements.
- Coordinate cross-campus regulatory activities and serve as a liaison among investigators, study staff, compliance personnel, and institutional stakeholders.
- Facilitate additional IRB approval requests.
- Serve as a content expert regarding Human Research Protection Program (HRPP) policies, procedures, and emerging regulatory requirements.
- Attend and participate in quarterly HRPP meetings and disseminate relevant updates to stakeholders.
- Coordinate and support informed consent and consent-process training activities.
- Prepare reports and summaries regarding site approval status, protocol compliance, and regulatory performance metrics.
- Support continuous improvement of IRB processes, workflows, and regulatory tracking systems.
- Participate in the development of program resources through literature searches, benchmarking, and review of industry best practices.
- Participate on committees relevant to human research protections, regulatory compliance, and program operations.
Knowledge – Skills – Abilities
Excellent oral and written communication skills are essential. Strong attention to detail, analytical thinking, organization, and project management skills required. Demonstrated knowledge of human subjects research regulations, IRB processes, and Human Research Protection Program requirements. Ability to manage multiple projects and deadlines while collaborating effectively with diverse stakeholder groups.
Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education: Bachelor’s Degree
Minimum Required Experience: 5 years
Preferred Education: Master’s degree in public health (MPH), Clinical Research, Health Sciences, Healthcare Administration, Research Administration, Regulatory Science, or related field.
Coursework or advanced training in human subjects research protections, research compliance, regulatory affairs, or clinical research administration.
Preferred Experience: Experience in clinical research, regulatory affairs, research administration, research compliance, or IRB administration. Demonstrated experience coordinating regulatory submissions and maintaining compliance within a human subjects research environment. Multi-site research experience. Experience supporting registry or observational research studies, central IRBs and reliance agreements, working in an academic medical center or research organization
Required Certification/Licensure(s): CITI training required within 90 days of hire
Preferred Certification/Licensure(s): Certified IRB Professional (CIP) preferred
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Physical Requirements
Work requires infrequent physical effort such as walking or retrieving materials.
Work Environment
May experience slightly disagreeable features such as temperature changes or noise from time to time. Work performed in an environmentally controlled environment.
Sensory Acuity
Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.
Why MCW?
- Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
- 403B Retirement Package
- Competitive Vacation and Paid Holidays offered
- Tuition Reimbursement
- Paid Parental Leave
- Employee & Family Assistance Program (EFAP)
- Pet Insurance
- On campus Fitness Facility, offering onsite classes
- Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.
For a brief overview of our benefits see: Benefits Overview
For a full list of positions see: MCW Careers
At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – Collaborative – Curiosity – Inclusive – Integrity – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.
MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.
