Clinical Research Assistant II, Surgery

JOB SUMMARY: The Department of Surgery is seeking highly motivated, detail-oriented individuals to serve as the primary coordinator for a diverse portfolio of human subject research studies. These include FDA-regulated clinical trials involving investigational drugs and medical devices pursuing market approval. Due to continued program growth, we have multiple open positions, making this an exciting opportunity to join a dynamic and expanding clinical research team! The Clinical Research Assistant II (CRA II) will coordinate assigned clinical trials and research studies under the direction of their principal investigator(s) and departmental leadership. This role requires exceptional organizational and communication skills, sound professional judgment, and a strong commitment to maintaining compliance with all regulatory requirements, institutional policies, and study protocols. This position is well suited for candidates with a strong foundation in the biomedical sciences and/or prior patient-facing healthcare experience. It also offers an excellent opportunity for individuals seeking additional clinical research or patient care experience in preparation for graduate school programs. This is a full-time position, Monday through Friday, based on our Dallas campus. Preferred candidates will have the flexibility to accommodate adjustments in work hours as needed to align with clinic operations and operating room schedules, ensuring appropriate support for research participants and patient care activities.

BENEFITS: UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: 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 UTSW employee benefits!

EXPERIENCE AND EDUCATION: Required Education High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree medical or science related field and no prior experience Experience 2 years experience with High School Diploma or 1 year experience with Associate's Degree Preferred Licenses and Certifications (BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements. (CPRAED) CPR AED may be required based on affiliate location requirements.

JOB DUTIES: 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. Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order. With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols. Assists in preparing studies for closeout, (e.g. packing files, documenting files for storage, shipping extra supplies back to sponsor). With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required. May perform patient care (basic skills) under the direction of PI following scope of work document. Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned. SECURITY AND EEO STATEMENT Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. EEO 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 on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.