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Job Summary
The Research Compliance Analyst is responsible for assisting with policy development, ensuring clinical trials are approved through the appropriate approval process, performing research billing audits, monitoring compliance with the CMS, FDA, etc. regulatory requirements as well as other applicable rules and laws, providing research education, and monitoring all research activities performed at the UMC Health System (UMC) with the objective of maximizing prudent research while minimizing patient and hospital risk.

Reports to: Chief Compliance Officer

Job Specific Responsibilities
Daily assignments may include but are not limited to:
• Reviews clinical research protocol proposals and makes recommendations regarding
Implementation.
• Develops a budget for all research proposals if UMC staff or resources will be used.
• Tracks implementation of all clinical trials once approval is granted.
• Ensures that research sponsors are billed appropriately for UMC staff and resources.
• Monitors studies for protocol compliance.
• Audits claims submitted to payors to ensure that research activities are billed correctly.
• Works closely with TTUHSC Clinical Research Office and IRB to coordinate research activities
and proposals.
• Works closely with the UMC Compliance Office and Internal Audit to ensure compliance with
all related laws and regulations including HIPAA, False Claims Act, FDA, and others.
• Responds to serious adverse events related to research, allegations of regulation and protocol
violations, and any impropriety in the conduct of research that might impact UMC.
• All other assigned duties as requested by the Corporate Compliance department.

Education and Experience
• High School Diploma or GED
• +5 years of experience in healthcare compliance and/or clinical research, preferably in a hospital setting.

Required Licensures/Certifications/Registrations
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) required, or if not certified will obtain certification within the first two years of start date.
• Or is currently certified in healthcare compliance (CHC).

Skills and Abilities
• Knowledge and prior experience in coding, billing, compliance, IRB, and auditing is helpful.
• Knowledge and understanding of federal and state laws governing clinical research is a plus.
• Ability to manage a large portfolio of ongoing research protocols.
• Must be able to prioritize multiple projects.
• Must have strong planning, organizational, and project management skills.
• Must have the ability to network and interact with leaders, researchers, and managers both internal and external to UMC.
• Excellent interpersonal oral language and writing skills is required.

Interaction with Other Departments and Other Relationships
The person in this role is required to work with many department directors, nursing staff, medical staff, TTUHSC, regulatory agencies, and administration.

Physical Capabilities
Work is of light physical demand. Near visual acuity is required. Walking, sitting, light lifting,
Communicating in English is expected.

Environmental/Working Conditions
This job is subject to inside environmental conditions. Protection from weather conditions, not necessarily from temperature changes.

Direct Reports
NA

UMC Health System provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

*Request for accommodations in the hire process should be directed to UMC Human Resources.​*