Research Nurse, Pediatrics-Neonatal & Perinatal Medicine

Job Summary
The Pediatrics Department has an opening for a Research RN to join the team. This role will oversee the following departmental tasks:
Screen participants for eligibility criteria and maintains subject level documentation for all studies independently.
Conduct and assist with study visits, perform research procedures and assessments, extract data from EPIC.
Perform transcutaneous auricular nerve stimulation per protocol while monitoring vital signs.
Conduct/document consent for participants applying knowledge of human subject's protection regulations in the informed consent process.
Complete IRB/Sponsor reportable events, apply protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
Ensure study teams are compliant with institutional requirements/policies, provides/maintains protocol specific training to staff and ensure appropriate study specific training plans per Delegation of Authority Logs.
Review study participant charges, identifies discrepancies and escalates to appropriate offices to ensure appropriate research billing compliance.
Experience and Education
Graduate of NLN (National League for Nursing) approved Nursing program, licensure as Registered Nurse by Board of Nurse Examiners for the State of Texas is required.
Two years clinical nursing experience required. Clinical research nursing experience is highly desirable but not required.
May substitute relevant clinical research experience for clinical nursing experience on one-on-one basis.
Experience working with pediatric patients, preferred.
Required Certifications
Attach a current Basic Life Support (BLS) certification through a course accredited by the American Heart Association (AHA) or American Red Cross (ARC) when you apply.
Job Duties
Nursing:
Performs nursing care, nursing assessment, and data collection for clinical research studies.
May provide working direction for research activities to nursing staff and/or other non-licensed medical or office support personnel.
Assists in resolving problems relating to patient care and acts as a liaison between the research team and other institutional stakeholders.
Gives counsel to patients with respect to medical conditions and provides appropriate guidance related to research activities, per the study protocol or under the supervision of the principal investigator.
Assists in developing procedures for inpatient and outpatient research activities, follows protocols in the scheduling of tests and procedures; may administer experimental and non-experimental medication and procedures under physician/principal investigator guidance.
Patient and Study Management:
Recruit’s patients for research studies ensuring subject eligibility, screens patients, tracks patients' data and explains the study purpose and content of each study.
Duties performed may include one or more of the following core functions:
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.
Obtains informed consent and follows the proper consenting process for patients and/or family members.
Monitors and evaluates patients involved in research studies within scope of practice, including their response to therapy or intervention.
May assist in inventory of investigational medication, devices or approved medication for each protocol and acts as liaison between investigator pharmacy as each protocol requires, as per protocol requirements.
Data and Regulatory Management:
May train other research nurses in specialized skills and knowledge necessary to perform variety of basic and complex research data collection and nursing care; may provide in-service education to staff members as appropriate.
May assist in clinical research data collection for pharmaceutical studies, Federal studies, or investigator-initiated studies in patient records (paper and electronic), sponsors documents (electronic and paper) and other forms for data collection, such as: medical histories, data collection of patients' charts for retrospective review studies, patient physiologic performance results and laboratory determinations, calculations of derived information, and maintenance of general research protocols and complex protocols. May also report information to other physicians, institutional stakeholders and granting agencies.
May collect, label, store and/or ship blood, serum, urine, and other specimens for analysis per the protocol requirements.
Documents and updates the physician and sponsors on the condition of the study participants including possible side effects of therapy.
Reports adverse events through appropriate sources per the policy of the protocol and the University Institutional Review Board (IRB) regulations.
May assist in organizing and preparing collected data for subsequent publication as appropriate.
May coordinate, as per the requirements of the study team, regulatory aspects for each study, which may include but is not limited to budgets, contracts, IRB submissions, maintenance of critical regulatory documents and other required committee submissions.
May assist in internal and/or external audit requests.
Occasionally, attends and participates in out-of-town meetings or scientific conferences as a representative of the research team.
Performs other duties as assigned.
COVID-19 Mandate
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/
To learn more about the benefits UT Southwestern offers, visit https://www.utsouthwestern.edu/employees/hr-resources/
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: why-work-here/diversity-inclusion