Clinical Research Assistant II, Endocrinology
Location: Texas-Dallas-5323 Harry Hines Blvd
About the role
UT Southwestern is a world‑renowned medical and research center with over 75 years of excellence in the Dallas‑Fort Worth area, ranked the #1 hospital in DFW by U.S. News & World Report. The institution is committed to excellence, innovation, teamwork, and compassion, offering a competitive benefits package that includes healthcare, PTO and paid holidays, on‑site childcare, wage increases, merit increases, and more. Employees enjoy opportunities for career growth and development aligned with future goals.
Job Summary: Works under the direction of an Investigator(s) with general supervision to provide ongoing data management for local and national research studies, may coordinate observational (non‑treatment/treatment) trials, prepares statistical information for subjects entered or removed from studies, identifies eligible subjects by chart review, prepares data for IRB submission, and handles confidential records and research materials.
Responsibilities
- Understands visit schedules, criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
- Assists research staff by completing research protocol related tasks.
- Reviews and abstracts information from medical records including eligibility criteria.
- Enters data into case report forms or other data collection system based on research study.
- Assists with maintenance of study level documentation.
- Assists with data queries and possible edits for accuracy.
- Compiles data for regulatory requirements and/or deadlines for local or sponsor submissions.
- Maintains existing databases and ensures data integrity.
- Performs QA/QC clinical analysis and data checks using various databases based on trial.
- Assists with preparing annual reports and/or modifications to institutional review board (IRB); this may include reportable events (UPIRSO).
- Assist and prepare research records for formal sponsor audits or internal audits.
- Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
- With adequate training and supervision, assists with participant screening and recruitment for more complex trials.
- Conducts and documents consent for participants in studies; assists with the development of consent plans and documents for participants.
- Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors.