Compliance Specialist, Healthcare

Case Western Reserve University is committed to providing a transparent estimate of the salary for this position at the time of its posting. The salary range is $46,035 - $50,000, depending on qualifications, experience, department budgets, and industry data.

Employees receive more than just a paycheck. University employees enjoy a comprehensive benefits package that includes excellent healthcare, retirement plans, tuition assistance, paid time off, and a winter recess.

Working under general supervision, the IRB Specialist provides technical protocol processing, operational review, and direct applicant support for the Case Western Reserve University Human Research Protection Program (HRPP) and Institutional Review Board (IRB). The specialist serves as a primary front-line liaison to IRB applicants, conducting preliminary compliance reviews, assisting study teams with application preparation, and facilitating daily IRB workflows in accordance with federal regulations (OHRP/FDA), state laws, and institutional policies.

• Serve as the primary operational point of contact for IRB applicants, providing responsive technical guidance to faculty, staff, and student investigators. Conduct pre-submission application reviews, advise applicants on consent form drafting, and assist study teams in navigating submission requirements. Conduct preliminary administrative and technical reviews of IRB submissions (new protocols, exempt/expedited reviews, modifications, continuing reviews, protocol deviations, adverse events, and terminations).
  
  Facilitate monthly and ad hoc IRB meeting logistics, prepare agendas, document board determinations, and translate board feedback into clear, actionable revisions for applicants. (50%)
• Work closely with the Executive Director or Director to help with the daily operational workflows for CWRU
  ¿ s Reliant Review Program supporting multi-site research under the Common Rule. Interface directly with internal and external applicants, collaborating institutional IRB administrators, and hospital coordinators to clarify study parameters, process reliance requests, execute SMART IRB platform entries, and track reliance agreements. (10%)
• Monitor and serve as the operational primary point of contact for shared departmental email accounts for the CWRU HRPP and IRB Offices resolving requests when possible and escalating when necessary. (10%)
• Participate in routine IRB quality improvement reviews, administrative file audits, and post-approval monitoring checks. Assist leadership with task execution and document preparation required for national accreditation (AAHRPP) reviews and external site visits. (10%)

Perform other duties as assigned. (5 %)

Department:
Daily with executive director for human research protection program, research compliance, associate directors for institutional review board, manager for regulatory compliance monitoring, research compliance team members, associate vice president for research, executive director of training technology, pre-award and post-award teams.

University:
Daily with university faculty, staff, and students, various school research administration departments, and direct contact with the chairpersons and members of the various committees the research compliance manager will support.

External:
Direct contact with affiliated hospital IRB offices, non-affiliated hospital and university IRB offices, and grants and contracts offices related to collaborative research activities. Direct contact with faculty and medical staff involved in research at affiliated and non-affiliated institutions collaborating with the university. Frequent contact with regulatory, accreditation, and professional societies related to research compliance.

Students:
Direct contact with undergraduate, graduate, and professional students and post-doctoral fellows and scholars to help them in their research endeavors.

No supervisory responsibility.

Experience:

2 years of related experience in research administration, IRB operations, human subjects research compliance, or customer-facing administrative/technical support.

Education:

Bachelor's degree required. Certified IRB Professional (CIP) designation preferred.

• Exceptional customer service and interpersonal skills; ability to communicate complex regulatory concepts clearly and constructively to IRB applicants, helping them resolve application issues…