Research Compliance Specialist

About the role

The Alice L. Walton School of Medicine (AWSOM) seeks a Research Compliance Specialist to support the school's commitment to ethical, compliant, and high-quality research.

Responsibilities

• Coordinate and manage day-to-day Office of Research regulatory and compliance operations.
• Serve as a subject matter resource to faculty investigators, students, research staff, institutional committees, sponsors, and external IRBs.
• Administer and continuously improve HRPP operations.
• Evaluate regulatory requirements and compliance risks.
• Facilitate and review protocol development, IRB submissions, amendments, continuing reviews, reportable events, study closures, and reliance activities.
• Monitor investigator and key personnel compliance obligations.
• Evaluate protocol deviations, noncompliance events, participant complaints, and corrective or preventive action plans.
• Maintain compliance calendars and deadline trackers for IRB submissions, federal and sponsor reporting, ClinicalTrials.gov obligations, grant-related regulatory requirements, audits, inspections, and committee review activities.
• Develop and maintain investigator-facing training materials, guidance documents, educational resources, and compliance communications.
• Analyze research compliance and operational metrics, identify emerging risks and trends, and contribute to strategic decisions.

Qualifications and Requirements

• Bachelor’s degree in health sciences, life sciences, public health, research administration, healthcare administration, education, business administration, or a related field.
• Certification or eligibility for certification such as Certified IRB Professional (CIP), Certified Research Administrator (CRA), or similar research administration or compliance credential, preferred.
• 4 years of experience in research administration, regulatory coordination, compliance support, grants support, academic administration, healthcare administration, or a related operational role.
• Prior experience in an academic, healthcare, clinical research, medical school, research compliance, IRB, HRPP, or grants administration setting, preferred.
• Experience supporting federal grants, multi-site studies, FDA-regulated research, reliance arrangements, or external IRB coordination, preferred.
• Demonstrated ability to interpret and apply research regulations, institutional policies, and sponsor requirements in support of compliant research operations, preferred.
• Familiarity with 45 CFR 46, FDA human subjects regulations, HIPAA privacy considerations, conflict of interest processes, sponsor requirements, or AAHRPP-aligned HRPP standards, preferred.
• Ability to analyze regulatory issues, evaluate compliance risks, and make independent recommendations regarding research administration processes and requirements.
• Strong organizational skills and attention to detail, with the ability to manage multiple workflows, deadlines, documents, and stakeholder requests in a growing program environment.
• Excellent written and verbal communication skills, including the ability to communicate professionally with faculty, students, staff, leaders, external partners, sponsors, and regulatory contacts.
• Ability to exercise sound judgment, maintain confidentiality, follow established procedures, and escalate questions or concerns appropriately.
• Proficiency with Microsoft Office Suite, calendar and meeting platforms, shared document systems, and project tracking tools.
• Experience with electronic IRB systems, ClinicalTrials.gov, federal reporting systems, CITI or equivalent training systems, or grant management platforms, preferred.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those required by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Physical Demands: In the work environment described, position requires utilizing a computer and a telephone for prolonged periods of time and good eye/hand coordination, bending and stretching, and physical stamina to lift and transport a minimum of 10 pounds. Visual acuity to review written materials is required for this job. Work Environment: Work is performed on-site (Monday-Friday, 8 a.m.-5 p.m.) in a professional, climate-controlled office environment with standard office equipment, including computers, printers, and telephones. This role requires working in an open setting near colleagues. The noise level is typically low to moderate. The role also requires interaction with both the public and internal team members in a professional and courteous manner. Some local travel will be required, and a flexible schedule may be necessary to accommodate business needs, including occasional evening and weekend work hours.

Benefits

The Alice L. Walton School of Medicine offers a comprehensive benefits package including health insurance, retirement savings plan, paid time off, and more.

Pay

The salary range for this position is $60,000 - $90,000 annually, commensurate with experience.

Schedule

The Research Compliance Specialist works Monday through Friday from 8:00 AM to 5:00 PM, with occasional evening and weekend work hours as needed.