Regulatory Monitoring Analyst, Human Research Protection

Location

Type, TX | United States

Job description

Why UT Southwestern?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. At UT Southwestern, we invest in you with opportunities for career growth and development that align with your future goals and help to provide security for you and your family. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more that are all available on the day you start work. UT Southwestern is honored to be a Veteran Friendly work environment that is home to approximately 800 veterans. We value your integrity, dedication, and the commitment you’ve made to our country. We’re proud to support your next mission. Ranked by Forbes as one of the Top 10 National Employers, we invite you to be a part of the UT Southwestern team where you’ll discover teamwork, professionalism, and consistent opportunities for growth.

Job Summary

UT Southwestern Medical Center is hiring for Regulatory Monitoring Analyst, Human Research Protection

The Human Research Protection Program is made up of a dedicated team of professionals who serve the research community to facilitate quality human research in a way that protects the rights, safety, and welfare of study participants and complies with ethical and legal standards for the conduct of science.

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.

Experience and Education

• Bachelor’s degree in business, healthcare administration, or related area, and five (5) years’ professional experience in compliance or regulatory affairs, with research monitoring or auditing activities, preferred.
• Prefer experience at an academic medical center leading multi-faceted project teams and developing and successfully implementing work plans based on risk-analysis. 

Job Duties

• Works under minimal supervision to manage and perform regulatory monitoring reviews of various Research Administration functions and activities of UT Southwestern. Conducts complex monitoring and assurance activities to determine adherence to internal controls, education/training requirements and compliance with established policies and procedures and regulatory requirements associated with various aspects of Research Administration. 1. Serves as team leader and project manager while conducting regulatory monitoring reviews of various Research Administration functions. Establishes goals, objectives, timelines and quality measures for the team’s work and deliverables.
• 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.
• **Other Duties: Performs other duties as assigned.

To learn more about the benefits UT Southwestern offers, visit

This position is security-sensitive and subject to Texas Education Code §51.215, which authorizes UT Southwestern to obtain criminal history record information. UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

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