Compliance Specialist

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.


Job Description


POSITION OBJECTIVE

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.


ESSENTIAL FUNCTIONS

1. 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%)
2. 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%)
3. 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%)
4. 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%)

NONESSENTIAL FUNCTIONS


Perform other duties as assigned. (5 %)


CONTACTS


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.


SUPERVISORY RESPONSIBILITY


No supervisory responsibility.


QUALIFICATIONS


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.


REQUIRED SKILLS

1. Exceptional customer service and interpersonal skills; ability to communicate complex regulatory concepts clearly and constructively to IRB applicants, helping them resolve application issues efficiently.
2. Strong analytical skills to review complex research protocols, consent documents, and study designs for completeness and regulatory alignment.
3. Exceptional organization and time-management skills; ability to manage a high volume of time-sensitive applicant submissions with high accuracy.
4. Proficiency with electronic IRB submission platforms (e.g., SpartaIRB/Cayuse, SmartIRB), database management, and virtual communication tools.
5. Demonstrated knowledge of, or willingness to learn and utilize, AI and automation tools to streamline applicant review checklists, draft routine correspondence, and optimize workflow efficiency.
6. Ability to maintain strict confidentiality, meet consistent attendance requirements, and interact face-to-face with colleagues and supervisors.
7. Ability to demonstrate successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest.
8. Ability to meet consistent attendance. Willingness to learn and work with artificial intelligence (AI) tools and technologies.

WORKING CONDITIONS


Typical office environment.


Hybrid Eligibility


This position is eligible for hybrid work arrangement up to two remote days per week at the discretion of the department. New employees may begin a hybrid schedule upon approval from the supervisor, successful completion of an orientation period and signing the remote work checklist certification form.


EEO Statement


Case Western Reserve University is an equal opportunity employer. All applicants are protected under federal and state laws and university policy from discrimination based on race, color, religion, sex, sexual orientation, gender identity or expression, national or ethnic origin, protected veteran status, disability, age and genetic information.

Reasonable Accommodations


Case Western Reserve University complies with the Americans with Disabilities Act regarding reasonable accommodations for applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the CWRU Office of Equity at View phone number on click.appcast.io to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicants will be made on a case-by-case basis.


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