UT Southwestern Medical Center - Dallas, TX

posted 2 months ago

Full-time - Mid Level
Dallas, TX
Hospitals

About the position

UT Southwestern Medical Center is hiring for the position of Regulatory Monitoring Analyst within the Human Research Protection program. This role operates under minimal supervision and is responsible for managing and performing regulatory monitoring reviews of various Research Administration functions and activities at UT Southwestern. The analyst will conduct complex monitoring and assurance activities to ensure adherence to internal controls, education and training requirements, and compliance with established policies, procedures, and regulatory requirements associated with various aspects of Research Administration. The Regulatory Monitoring Analyst will serve as a team leader and project manager, establishing goals, objectives, timelines, and quality measures for the team's work and deliverables. This position involves conducting assurance and effectiveness reviews of compliance activities in accordance with appropriate standards and metrics, as well as the established compliance plans and departmental policies. The analyst will develop monitoring plan tools for assessment, sampling methodologies, and solutions to implement post-monitoring in the respective areas, including research teams and research offices. In addition, the analyst will evaluate the effectiveness of research regulatory and compliance controls used by the reviewed departments, ensuring adherence to all applicable university research policies and procedures. The role includes creating monitoring reports with supporting evidence, defending findings and recommendations regarding identified regulatory or procedural deficiencies, and assisting the Vice President for Research Administration and Research Administration Directors in investigations of alleged breaches of policy or misconduct. The analyst will also respond to audit findings identified by Internal Audit and external agencies, assist with export control reviews, and maintain effective working relationships with Research Administration and compliance personnel to achieve the objectives of assurance-related assignments. Furthermore, the analyst will remain updated on current developments in research administration and regulatory compliance, coordinate with respective areas to maintain policies and procedures, and develop and conduct training sessions on compliance-related topics as needed.

Responsibilities

  • Manage and perform regulatory monitoring reviews of various Research Administration functions.
  • Conduct complex assurance and effectiveness reviews of compliance activities.
  • Establish goals, objectives, timelines, and quality measures for the team's work and deliverables.
  • Develop monitoring plan tools for assessment and implement post-monitoring solutions.
  • Evaluate effectiveness of research regulatory and compliance controls used by reviewed departments.
  • Create monitoring reports with supporting evidence and defend findings regarding regulatory deficiencies.
  • Assist in investigations of alleged breaches of policy or misconduct.
  • Respond to audit findings identified by Internal Audit and external agencies.
  • Coordinate with Research Administration and compliance personnel to achieve assurance-related objectives.
  • Develop and conduct training sessions on compliance-related topics.

Requirements

  • Bachelor's degree in business, healthcare administration, or a related area.
  • Five (5) years of professional experience in compliance or regulatory affairs, with research monitoring or auditing activities.

Nice-to-haves

  • Experience at an academic medical center leading multi-faceted project teams.
  • Experience developing and successfully implementing work plans based on risk-analysis.

Benefits

  • Childcare
  • Health insurance
  • Paid time off
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