Regulatory Monitoring Analyst, Office of Research Regulatory Affairs at UT Southwestern Medical Center

Dallas, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Clinical Research Monitoring, Auditing, Quality Assurance, Federal Regulations, ICH-GCP Guidelines, HIPAA Guidelines, Project Management, Risk Analysis, Monitoring Plan Development, Training Development, Investigative Skills, Communication Skills, Team Collaboration, Policy Development, Research Administration

Industry

Higher Education

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. 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 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. 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%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 Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION Required Education Bachelor's Degree In business, healthcare administration, or related area. or Experience 5 years Professional experience in compliance or regulatory affairs, with research monitoring or auditing activities. and Experience at an academic medical center leading multi-faceted project teams, and developing and successfully implementing work plans based on risk-analysis. 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. 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. 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. 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.

Responsibilities

The Regulatory Monitoring Analyst conducts compliance reviews and develops monitoring plans to ensure adherence to research regulations. They also assist in investigations of policy breaches and maintain effective relationships with compliance personnel.