Clinical Research Assistant II, Endocrinology

UT Southwestern Medical Center•Dallas, TX

About The Position

The Clinical Research Assistant II works under the direction of one or more investigators with general supervision, providing ongoing data management for local and national research studies and potentially coordinating observational or treatment trials and studies. The role may support more complex studies under the direction of the principal investigator, Clinical Research Coordinator, and/or Clinical Research Lead. Responsibilities include preparing statistical information for study participants, identifying eligible subjects through chart review, preparing information for IRB submissions, and handling confidential records and research materials.

Requirements

  • High school diploma plus 2 years of experience; or an associate's degree in a medical- or science-related field plus 1 year of experience; or a bachelor's degree in a medical- or science-related field with no prior experience.
  • BLS (Basic Life Support) may be required based on affiliate location requirements.
  • CPR AED may be required based on affiliate location requirements.

Nice To Haves

  • Bachelor's degree in a medical- or science-related field.
  • Patient-facing experience, such as Medical Assistant, Phlebotomist, Scribe, or similar.

Responsibilities

  • Understand visit schedules, eligibility criteria, and protocol requirements for low-complexity trials, and schedule research visits.
  • Complete research protocol-related tasks in support of research staff.
  • Review and abstract medical-record information, including eligibility criteria.
  • Enter study data into case report forms or other data-collection systems and help maintain study documentation.
  • Assist with data queries and edits to support accuracy.
  • Compile data for regulatory requirements and local or sponsor submission deadlines.
  • Maintain databases and ensure data integrity.
  • Perform clinical analysis and data quality checks using databases relevant to the trial.
  • Assist with annual reports and IRB modifications, including reportable events (UPIRSO).
  • Prepare research records for formal sponsor or internal audits.
  • Recruit and enroll patients, which may include consenting patients after training and under supervision.
  • Assist with screening and recruitment for more complex trials after adequate training and supervision.
  • Conduct and document participant consent, and assist with developing consent plans and documents.
  • Identify incomplete, inaccurate, or missing data for more complex studies and work with the lead coordinator to correct errors.
  • Assist with ordering and maintaining research supplies in accordance with university and department procedures, and ensure equipment is in good working order.
  • Assist with collecting and processing specimens according to established procedures and protocols after adequate training and supervision.
  • Assist with study closeout, including packing and documenting files for storage and shipping extra supplies back to the sponsor.
  • Perform study procedures such as phlebotomy, vital signs, and EKGs when appropriately trained, credentialed, and supervised; other procedures, equipment, or services may be required depending on the study.
  • Perform basic patient care under the direction of the PI and in accordance with the scope-of-work document.
  • Perform other duties as assigned.

Benefits

  • PPO medical plan, available day one at no cost for full-time employee-only coverage.
  • Preventive healthcare coverage at 100% with no copay.
  • Paid time off available day one.
  • Retirement programs through the Teacher Retirement System of Texas (TRS).
  • Paid parental leave.
  • Wellness programs.
  • Tuition reimbursement.
  • Public Service Loan Forgiveness (PSLF) qualified employer.
  • On-site childcare.
  • Paid holidays.
  • Merit increases.
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