Clinical Trials Regulatory Associate

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

TRS Retirement

Paid Parental Leave

Tuition Reimbursement

Job summary

UT Southwestern Medical Center in Dallas seeks a Regulatory Associate to ensure compliance with federal regulations for human subjects research and animal care. You will review study protocols, draft consent forms, complete IRB/FDA submissions, and maintain regulatory documents.

The role includes supervising junior staff, guiding tasks, and supporting DOT clinical trials, with opportunities for training and career growth within a premier medical center.

Qualifications

• Bachelor's Degree or equivalent required.
• 2 years of related experience; may consider experience and education in lieu of requirements.

Responsibilities

• Review study protocols, consent documents, and related materials to ensure compliance with applicable requirements.
• Provide supervision and guidance to junior Regulatory Assistants, assign tasks, and review work for accuracy.
• Administer expedited and exempt review processes, including intake of protocols and assessment of review level for IRB/IACUC determinations.
• Provide guidance to investigators on IRB/IACUC submissions, study performance, and compliance documentation.
• Contribute to development or updates of IRB/IACUC guidance, procedures, forms, and QA activities.
• Perform other duties as assigned.

Skills

Regulatory knowledge

IRB/IACUC familiarity

Study protocol review

Documentation & recordkeeping

Education

Bachelor's Degree or equivalent

Job description

UT Southwestern Medical Center in Dallas seeks a Regulatory Associate to ensure compliance with federal regulations for human subjects research and animal care. You will review study protocols, draft consent forms, complete IRB/FDA submissions, and maintain regulatory documents.

The role includes supervising junior staff, guiding tasks, and supporting DOT clinical trials, with opportunities for training and career growth within a premier medical center.