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UT Southwestern Medical Center is hiring for Clinical Research Assistant II, Internal Medicine-Nephrology

This will be the primary research study coordinator for a funded NIH study, as well as other funded Nephrology clinical research studies. The expected duties include screening of clinic rosters for eligible patients, recruitment of study participants, informed consent, scheduling study patients for research study visits, administration of self-report questionnaires to participants for collection of patient-reported outcomes, entry of data into research database, and assisting the PI in collection of data for reporting of adverse events. Phlebotomy and collection and processing of samples is also required. The person should be willing to be trained to draw blood and process samples if they do not have those skill sets already. A Spanish-speaking person is preferred given the patient population.

• High School and 2 years of experience, Associate's degree in medical or science related field and 1 year of experience,
• Bachelor's degree in medical or science related field and no prior experience.
• A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on affiliate location requirements.

• May perform some or all of the following based on research study:
• Understands visit schedules, inclusion/exclusion 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. 11.
• 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.

• Knowledge of applicable Federal and institutional regulations governing clinical research.
• Knowledge of clinical research protocols.
• Effective organizational skills and attention to detail.
• Proactively works to maximize results of the team and organization.
• Follows and understands the regulations for Protected Health Information (PHI).
• Proactively works to maximize results of the team and organization
• Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
• Possess good communication skills.
• Possess the ability to problem solve.
• Work requires ability to conduct interviews with research subjects.

• Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients.
• May require local or out-of-state travel based on research study.

To learn more about the benefits UT Southwestern offers, visit https://www.utsouthwestern.edu/employees/hr-resources/

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.