UT Southwestern Medical Center
Regulatory Associate, Simmons Cancer Center
UT Southwestern Medical Center, Dallas, Texas, United States, 75215
Overview
Regulatory Associate, Simmons Cancer Center. Join UT Southwestern Medical Center as a Regulatory Associate in Simmons Comprehensive Cancer Center Education and Training Office for cancer research. Be part of a team of top cancer specialists and participate in innovative therapies, cutting-edge research, and life-changing clinical trials. You will support regulatory activities for a Disease Oriented Team (DOT) clinical trials under the leadership of the Cancer Center Associate Director of Clinical Research, and may provide backup for other DOTs as needed. Responsibilities
Review study protocols, informed consent documents, responses to stipulations, and other study-related documentation to ensure conformance with applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including intake of protocols and assessment of review level, with referral to full IRB/IACUC when applicable; conduct regular meetings with IRB/IACUC Chairs for final determinations; draft correspondence to investigators regarding IRB/IAC/IAC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource on human subject protection and animal care and use. Participate in development or updates to IRB/IACUC guidance, office procedures, related forms, database improvements, and other quality assurance activities. Perform other duties as assigned. Qualifications
Education
Bachelor's Degree - OR - equivalent
Experience
2 years of related experience May consider experience and education in lieu of requirements.
Benefits
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 UT Southwestern employee benefits Job Details
Primary Location : Texas-Dallas-5323 Harry Hines Blvd Work Locations : 5323 Harry Hines Blvd Job : Professional & Executive Organization : 371014 - SCC-Clinical Research Office Schedule : Full-time Shift : Day Job Employee Status : Regular Job Type : Standard Job Posting : Aug 12, 2025, 3:38:08 AM Security and Equal Employment Opportunity
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 access to critical infrastructure, maintaining security or integrity is a minimum qualification to be hired and to continue to be employed in the position. 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 based on race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. #J-18808-Ljbffr
Regulatory Associate, Simmons Cancer Center. Join UT Southwestern Medical Center as a Regulatory Associate in Simmons Comprehensive Cancer Center Education and Training Office for cancer research. Be part of a team of top cancer specialists and participate in innovative therapies, cutting-edge research, and life-changing clinical trials. You will support regulatory activities for a Disease Oriented Team (DOT) clinical trials under the leadership of the Cancer Center Associate Director of Clinical Research, and may provide backup for other DOTs as needed. Responsibilities
Review study protocols, informed consent documents, responses to stipulations, and other study-related documentation to ensure conformance with applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including intake of protocols and assessment of review level, with referral to full IRB/IACUC when applicable; conduct regular meetings with IRB/IACUC Chairs for final determinations; draft correspondence to investigators regarding IRB/IAC/IAC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource on human subject protection and animal care and use. Participate in development or updates to IRB/IACUC guidance, office procedures, related forms, database improvements, and other quality assurance activities. Perform other duties as assigned. Qualifications
Education
Bachelor's Degree - OR - equivalent
Experience
2 years of related experience May consider experience and education in lieu of requirements.
Benefits
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 UT Southwestern employee benefits Job Details
Primary Location : Texas-Dallas-5323 Harry Hines Blvd Work Locations : 5323 Harry Hines Blvd Job : Professional & Executive Organization : 371014 - SCC-Clinical Research Office Schedule : Full-time Shift : Day Job Employee Status : Regular Job Type : Standard Job Posting : Aug 12, 2025, 3:38:08 AM Security and Equal Employment Opportunity
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 access to critical infrastructure, maintaining security or integrity is a minimum qualification to be hired and to continue to be employed in the position. 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 based on race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. #J-18808-Ljbffr