Research Program Coordinator III-CIMBTR IRB

Medical College of Wisconsin•Milwaukee, WI

About The Position

The Research Program Coordinator III-CIMBTR IRB works 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. The role manages regulatory processes to ensure compliance with Human Research Protection Program (HRPP) requirements, institutional policies, and applicable federal regulations governing human subjects research. It serves as a subject matter resource for IRB-related activities across a large network of participating research centers and facilitates timely protocol review, approval, and maintenance. The coordinator oversees IRB activities for assigned protocols, manages continuing reviews and protocol changes, monitors site approvals and regulatory milestones, and facilitates communication among CIBMTR, MCW, participating research centers, investigators, study staff, and other stakeholders. The position also supports informed consent training, reporting, process improvement, and program resources.

Requirements

Bachelor’s degree; appropriate experience may substitute for education on an equivalent basis.
At least 5 years of experience; appropriate experience may substitute for education on an equivalent basis.
Demonstrated knowledge of human subjects research regulations, IRB processes, and HRPP requirements.
Excellent oral and written communication skills.
Strong attention to detail, analytical thinking, organization, and project management skills.
Ability to manage multiple projects and deadlines while collaborating effectively with diverse stakeholder groups.
CITI training required within 90 days of hire.

Nice To Haves

Master’s degree in public health (MPH), clinical research, health sciences, healthcare administration, research administration, regulatory science, or a related field.
Coursework or advanced training in human subjects research protections, research compliance, regulatory affairs, or clinical research administration.
Experience in clinical research, regulatory affairs, research administration, research compliance, or IRB administration.
Demonstrated experience coordinating regulatory submissions and maintaining compliance in a human subjects research environment.
Multi-site research experience.
Experience supporting registry or observational research studies.
Experience with central IRBs and reliance agreements.
Experience working in an academic medical center or research organization.
Certified IRB Professional (CIP) certification.

Responsibilities

Serve as the CIBMTR MCW primary coordinator for IRB activities associated with assigned research database protocols.
Manage Annual Continuing Progress Reviews (CPRs), including timely submissions, approvals, and follow-up actions.
Coordinate protocol amendments, revisions, renewals, and closures.
Liaise on IRB communications among CIBMTR, MCW, and participating research centers.
Monitor IRB approval status, expiration dates, and documentation requirements for more than 200 participating sites.
Develop and maintain systems to track protocol approval status, site participation, and regulatory milestones.
Monitor utilization of the NMDP Central IRB and identify sites using alternative IRB review processes.
Work with participating centers to understand and document local IRB review pathways and approval requirements.
Collaborate with the Research Database Protocol team and participating sites to support ongoing protocol and regulatory compliance.
Coordinate cross-campus regulatory activities and liaise among investigators, study staff, compliance personnel, and institutional stakeholders.
Facilitate additional IRB approval requests.
Serve as a content expert on HRPP policies, procedures, and emerging regulatory requirements.
Attend quarterly HRPP meetings and disseminate relevant updates to stakeholders.
Coordinate and support informed consent and consent-process training activities.
Prepare reports and summaries on site approval status, protocol compliance, and regulatory performance metrics.
Support continuous improvement of IRB processes, workflows, and regulatory tracking systems.
Contribute to 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.

Benefits

Healthcare coverage, including health, vision, and dental insurance.
Flexible Spending options.
403B retirement package.
Competitive vacation and paid holidays.
Tuition reimbursement.
Paid parental leave.
Employee & Family Assistance Program (EFAP).
Pet insurance.
On-campus fitness facility with onsite classes.
Discounted rates on select cell phone plans, local fitness facilities, Milwaukee recreation, and entertainment.