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Form of workThe Pediatrics Department has an open for a Clinical Research Assistant I (CRA I) to join the Pediatric ER division. This position will support several clinical trials and studies in the Pediatric ER division and will be stationed in the Children's Medical Center Emergency Department. The CRA I will provide study-related services ranging from, participant recruitment, consenting, coordinating, answering queries, creating databases, completing source documents and case report forms, and data entry. The schedule is flexible, with the possibility of working some nights/weekends/holidays expected.
Experience and Education
- High School diploma or GED with no experience.
- Prior clinical trials experience (particularly with pediatric patients) preferred.
- Preferred certifications: CITI and/or GCP
- A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
Compliance with the COVID-19 vaccine mandate enforced by the Centers for Medicare and Medicaid (CMS) is a requirement for this position. Federal law requires individuals holding this position to be fully vaccinated or have an approved exemption for certain medical, disability, or religious reasons. Individuals who do not meet CMS vaccination requirements are not eligible and should not apply for this position but are encouraged to apply for other non-healthcare positions at UT Southwestern for which they qualify.
For COVID-19 vaccine information, applicants should visit https://www.utsouthwestern.edu/covid-19/work-on-campus/
Job Duties
May perform some or all the following based on research study:
- 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.
- Understands visit schedules, inclusion/exclusion criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted), schedules research visits.
- Assists research staff by completing research protocol related tasks.
- Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
- Reviews and abstracts information from medical records including eligibility criteria.
- Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
- 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 EKGs needed for research study. Based on research study, other procedures/equipment/services may be required.
- Duties performed may include one or more of the following core functions:
- a) 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).
- Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
- Performs other duties as assigned.
- Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
- Follows and understands the regulations for Protected Health Information (PHI).
- Proactively works to maximize results of the team and organization.
- Possess good communication skills.
- Possess the ability to problem solve.
- Work requires ability to conduct interviews with research subjects.
This position is security-sensitive and subject to Texas Education Code • 51.215, which authorizes UT Southwestern to obtain criminal history record information. 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.
To learn more, please visit: https://jobs.utsouthwestern.edu/why-work-here/diversity-inclusion
