Regulatory Monitoring Analyst 2 - Regulatory Support and Monitoring

WHY UT SOUTHWESTERN?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY
Works under minimal supervision to manage and conduct regulatory monitoring reviews of Research Administration functions. Performs complex monitoring, assurance, and administrative activities for IRB�`approved human research studies. Supports external audits, for�`cause investigations, and sponsor�`investigator monitoring services. Contributes to development and maintenance of QAM processes and tools, including SOPs, checklists, and REDCap instruments, and participates in training to ensure compliance with institutional and regulatory requirements.

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include\:

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% 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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education

Bachelor's Degree degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related area is required.

• Experience

3 years of professional experience in research compliance.
Knowledge of federal regulations governing research required.

Preferred

• Experience

Previous experience as a Clinical Research Associate (CRA) is preferred.
Prefer experience at an academic medical center leading multi-faceted project teams and developing and successfully implementing work plans based on risk-analysis.

• Licenses and Certifications

Certification/coursework completion in clinical research monitoring or healthcare compliance is preferred, including Certified in Healthcare Research Compliance (CHRC).

JOB DUTIES

• Conducts complex assurance/effectiveness reviews of compliance activities in accordance with appropriate standards, metrics, established compliance plan(s) and prescribed departmental/unit/program policies. Establishes goals, objectives, timelines and quality measures for the team‿s work and deliverables.
• Review ClinicalTrials.gov submissions and provide feedback and support for human research studies across UTSW and affiliated entities, including data collection, record maintenance, results reporting, and resolution of problem records.
• Tracking, notifications, and follow up for ClinicalTrials.gov records, annual record verification, results reporting and verification of responsible party determinations.
• Provides guidance to Sponsor Investigator for their regulatory activities, including consultations, submissions, tracking of active INDs, IDEs, and sINDs, and issuance of annual report reminders and regulatory notifications. This includes reviewing materials prior to submission to the FDA and providing guidance.
• 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.
• Works with respective areas of Research Administration Leadership team to assist with for-cause investigations, alleged breaches of policy, research misconduct or other acts of non-compliance to determine cause, extent of loss and mechanisms for prevention.
• Serves as a lead monitor on not-for-cause post-approval monitoring of UTSW IRB approved studies, sponsor-investigator monitoring services, assist study teams in preparation for external agency audit (FDA, Sponsor, etc.) support services and/or other requested investigations by the IRB or compliance department(s). Assists Research Administration in responding to audit findings identified by Internal Audit and external agencies.
• Collaborates with Export Control office, Research Security office and Conflict of Interest office and conducts reviews referred to or requested by Research Administration, as needed.
• Creates monitoring reports with supporting evidence, and defends findings and recommendations made regarding identified regulatory or procedural deficiencies that may affect research compliance.
• Collaborates with direct supervisor and Regulatory Monitoring Analyst Senior to identify and recommend studies with past non-compliance, and/or regulatory issues for upcoming study assignments and monitoring visits selection.
• Maintains effective working relationships with Research Administration and compliance personnel to achieve objectives of assurance-related assignments, 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.
• Collaborates with IRB, regulatory, ClinicalTrials.gov, and other institutional regulatory partners to support effective education of research staff and investigators on regulatory compliance and ethical research conduct.
• Evaluates the need for innovative monitoring visit types, provides recommendations, and assists or independently develops new monitoring visit types, as assigned. Assist investigators to understand and comply with the ethical guidelines and regulatory requirements for research.
• Performs other duties, as assigned.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 117.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position.

EEO
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.WHY UT SOUTHWESTERN?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY
Works under minimal supervision to manage and conduct regulatory monitoring reviews of Research Administration functions. Performs complex monitoring, assurance, and administrative activities for IRB�`approved human research studies. Supports external audits, for�`cause investigations, and sponsor�`investigator monitoring services. Contributes to development and maintenance of QAM processes and tools, including SOPs, checklists, and REDCap instruments, and participates in training to ensure compliance with institutional and regulatory requirements.

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include\:

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% 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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education

Bachelor's Degree degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related area is required.

• Experience

3 years of professional experience in research compliance.
Knowledge of federal regulations governing research required.

Preferred

• Experience

Previous experience as a Clinical Research Associate (CRA) is preferred.
Prefer experience at an academic medical center leading multi-faceted project teams and developing and successfully implementing work plans based on risk-analysis.

• Licenses and Certifications

Certification/coursework completion in clinical research monitoring or healthcare compliance is preferred, including Certified in Healthcare Research Compliance (CHRC).

JOB DUTIES

• Conducts complex assurance/effectiveness reviews of compliance activities in accordance with appropriate standards, metrics, established compliance plan(s) and prescribed departmental/unit/program policies. Establishes goals, objectives, timelines and quality measures for the team‿s work and deliverables.
• Review ClinicalTrials.gov submissions and provide feedback and support for human research studies across UTSW and affiliated entities, including data collection, record maintenance, results reporting, and resolution of problem records.
• Tracking, notifications, and follow up for ClinicalTrials.gov records, annual record verification, results reporting and verification of responsible party determinations.
• Provides guidance to Sponsor Investigator for their regulatory activities, including consultations, submissions, tracking of active INDs, IDEs, and sINDs, and issuance of annual report reminders and regulatory notifications. This includes reviewing materials prior to submission to the FDA and providing guidance.
• 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.
• Works with respective areas of Research Administration Leadership team to assist with for-cause investigations, alleged breaches of policy, research misconduct or other acts of non-compliance to determine cause, extent of loss and mechanisms for prevention.
• Serves as a lead monitor on not-for-cause post-approval monitoring of UTSW IRB approved studies, sponsor-investigator monitoring services, assist study teams in preparation for external agency audit (FDA, Sponsor, etc.) support services and/or other requested investigations by the IRB or compliance department(s). Assists Research Administration in responding to audit findings identified by Internal Audit and external agencies.
• Collaborates with Export Control office, Research Security office and Conflict of Interest office and conducts reviews referred to or requested by Research Administration, as needed.
• Creates monitoring reports with supporting evidence, and defends findings and recommendations made regarding identified regulatory or procedural deficiencies that may affect research compliance.
• Collaborates with direct supervisor and Regulatory Monitoring Analyst Senior to identify and recommend studies with past non-compliance, and/or regulatory issues for upcoming study assignments and monitoring visits selection.
• Maintains effective working relationships with Research Administration and compliance personnel to achieve objectives of assurance-related assignments, 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.
• Collaborates with IRB, regulatory, ClinicalTrials.gov, and other institutional regulatory partners to support effective education of research staff and investigators on regulatory compliance and ethical research conduct.
• Evaluates the need for innovative monitoring visit types, provides recommendations, and assists or independently develops new monitoring visit types, as assigned. Assist investigators to understand and comply with the ethical guidelines and regulatory requirements for research.
• Performs other duties, as assigned.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 117.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position.

EEO
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.