Regulatory Monitoring Analyst, Office of Research Regulatory Affairs

UT Southwestern Medical Center • Dallas, TX

8d • Hybrid

About The Position

Regulatory Monitoring Analyst role has a hybrid (remote and onsite) work environment. This position involves conducting clinical research monitoring, auditing, quality assurance reviews, internal quality reviews and other administrative and regulatory reporting tasks with minimal supervision. Application-based knowledge of federal regulations, ICH-GCP guidelines, HIPAA guidelines are vital in conducting job duties effectively. Experience in pharmaceutical/biomedical industry or contract research organization or academic medical center conducting clinical research monitoring/compliance reviews is a plus.

Requirements

• Bachelor's Degree In business, healthcare administration, or related area.
• 5 years Professional experience in compliance or regulatory affairs, with research monitoring or auditing activities.
• Experience at an academic medical center leading multi-faceted project teams, and developing and successfully implementing work plans based on risk-analysis.

Nice To Haves

• Experience in pharmaceutical/biomedical industry or contract research organization or academic medical center conducting clinical research monitoring/compliance reviews is a plus.

Responsibilities

• Conducts complex assurance/effectiveness reviews of compliance activities in accordance with appropriate standards, metrics, established compliance plan(s) and prescribed departmental/unit/program policies.
• Develops monitoring plan tools for use in assessment, and the sampling methodologies and solutions to implement post monitoring in the respective area (research team and research offices).
• Evaluates effectiveness of research regulatory/compliance controls used by reviewed department/unit/program, as well as adherence with all applicable university research policies and procedures. Develops metrics within respective areas of Research Administration for evaluating effectiveness of controls and operational areas.
• Creates monitoring reports with supporting evidence, and defends findings and recommendations made regarding identified regulatory or procedural deficiencies that may affect research compliance.
• Assists Vice President for Research Administration and Research Administration Directors in investigations of alleged breaches of policy, misconduct or other acts of non-compliance to determine cause, extent of loss and mechanisms for prevention.
• Assists Vice President for Research Administration and Research Administration Directors in responding to audit findings identified by Internal Audit and external agencies.
• Assists with export control reviews referred to Research Administration.
• Maintains effective working relationships with Research Administration and compliance personnel to achieve objectives of assurance-related assignments, including coordination with the Research Compliance Officer and Research Compliance Committee to ensure operational activities integrate with institutional compliance activities.
• Remains abreast of current developments and topics in research administration and research regulatory compliance, and coordinates with respective areas of Research Administration to disseminate information.
• Works with respective areas of Research Administration to coordinate and maintain policies and procedures, and to maintain compliance-related education and training materials. Develops and conducts training sessions on compliance-related topics for research administrative areas, as needed.
• Performs other duties, as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees