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UT Southwestern Medical Center

Academic medical center and health system

Clinical Research Assistant 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeDallas, TX, USANo salary listed

About the Job

Requirements

  • A High School Diploma, an Associate's Degree in a medical or science-related field, or a Bachelor's Degree in a medical or science-related field is required.
  • With a High School Diploma, 2 years of experience are required; with an Associate's Degree, 1 year of experience is required.
  • Phlebotomy certification is required within 6 months of hire.
  • Candidates must have their own car to collect blood from offsite patients when needed.
  • Knowledge of applicable federal and institutional regulations governing clinical research is required.
  • Knowledge of clinical research protocols is required.
  • Effective organizational skills and attention to detail are required.
  • Candidates must follow and understand regulations for Protected Health Information (PHI).
  • Strong computer skills, including spreadsheets, databases, and interactive web-based software, are required.
  • The role requires the ability to conduct interviews with research subjects.
  • The role requires the ability to draw blood from adult and pediatric study patients.

Responsibilities

  • Collect, process, and ship research clinical trial patient blood samples.
  • Maintain study subject consent files and institutional review board records, and enter subject data into databases.
  • Assist the principal investigator with institutional review board record keeping and obtaining informed consent from subject families; respond to study inquiries and sponsor audit information requests on behalf of the principal investigator.
  • Understand visit schedules, criteria, and protocol requirements for low-complexity trials, such as questionnaire, data registry, or scripted trials, and schedule research visits.
  • Assist research staff by completing research protocol-related tasks.
  • Review and abstract information from medical records, including eligibility criteria.
  • Enter data into case report forms or other study data collection systems and assist with maintaining study-level documentation.
  • Assist with data queries and possible edits for accuracy.
  • Compile data for regulatory requirements and deadlines for local or sponsor submissions.
  • Maintain existing databases and ensure data integrity.
  • Perform clinical analysis quality assurance and quality control and data checks using databases based on the trial.
  • Assist with preparing annual reports and/or modifications to the institutional review board, including reportable events.
  • Assist with and prepare research records for formal sponsor audits or internal audits.
  • Recruit and enroll patients in research studies, which may include consenting patients after training and with supervision.
  • With adequate training and supervision, assist with participant screening and recruitment for more complex trials.
  • Conduct and document participant consent in studies; assist with developing consent plans and participant 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 according to university and department procedures, and ensure equipment is in good working order.
  • With adequate training and supervision, assist with collecting and processing specimens according to established procedures and protocols.
  • Assist in preparing studies for closeout, including packing files, documenting files for storage, and shipping extra supplies back to the sponsor.
  • With adequate training, credentialing, and supervision, perform study procedures such as phlebotomy, vital signs, and electrocardiograms as needed for the research study; other procedures, equipment, or services may be required based on the study.
  • May perform basic patient care under the principal investigator's direction and according to the scope of work document.
  • Perform duties involving one or more of the following: directly interacting with or caring for patients; directly interacting with or caring for human-subjects research participants; regularly maintaining, modifying, releasing, or similarly affecting patient records, including patient financial records; or regularly maintaining, modifying, releasing, or similarly affecting human-subjects research records.
  • Perform other duties as assigned.

Desired Qualifications

  • Basic Life Support may be required based on affiliate location requirements.
  • Cardiopulmonary Resuscitation and Automated External Defibrillator certification may be required based on affiliate location requirements.

About the Company

UT Southwestern Medical Center

Academic medical center and health system

UT Southwestern Medical Center is an academic medical center in Dallas, Texas, integrating patient care, biomedical research, and medical education. It operates a main campus and regional medical centers alongside four schools, including a medical school and graduate programs in health professions and public health. What sets UT Southwestern apart is research output ranked No. 1 worldwide by the Nature Index, backed by Nobel laureates on faculty. The goal is to advance medical discovery into better treatments and compassionate patient care.

Company size
Not listed
Company stage
Grant
Total funding
$18M
Headquarters
Dallas, TX
Founded
Not listed

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