<p>WHY UT SOUTHWESTERN?</p> <p>With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!</p> <p>JOB SUMMARY</p> <p>This position works under moderate supervision of the research manager, physician, mid-level provider, and/or nurse to provide nursing care in a medical facility, clinic, or laboratory setting involving medical research efforts with inpatients and outpatients. Responsible for all regulatory aspects of research studies, coordination of study procedures, and patient enrollment and participation in research studies. Must be able to conduct clinical trial screening and recruitment on complex research studies, perform clinical trial visits, that may include subcutaneous or intravenous study drug administration, process clinical research samples (such as centrifugation and aliquoting), ship samples using International Air Transport Association (IATA) protocols, complete data entry into Electronic Data Capture (EDC) systems, and complete necessary regulatory paperwork, including familiarity with IRB submissions. The ideal applicant is familiar with screening and conducting complex clinical trial visits and completing the necessary regulatory paperwork associated with a clinical trial. The applicant should be ready to mentor less experienced team members and may be assigned some team leadership / supervisory roles. The preferred applicant will have experience with EPIC EMR, IRB submissions, and be proficient with Microsoft 365 Suite. Must have experience and comfort with phlebotomy.</p> <p>BENEFITS</p> <p>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:</p> <ul> <li>PPO medical plan, available day one at no cost for full-time employee-only coverage </li><li>100% coverage for preventive healthcare-no copay </li><li>Paid Time Off, available day one </li><li>Retirement Programs through the Teacher Retirement System of Texas (TRS) </li><li>Paid Parental Leave Benefit </li><li>Wellness programs </li><li>Tuition Reimbursement </li><li>Public Service Loan Forgiveness (PSLF) Qualified Employer </li><li>Learn more about these and other UTSW employee benefits! </li></ul> <p>EXPERIENCE AND EDUCATION</p> <p>Required</p> <ul> <li>Education </li></ul> <p>Associate's Degree or advanced degree</p> <p>Graduate of NLN (National League for Nursing) approved Nursing program</p> <ul> <li>Experience </li></ul> <p>4 years of clinical nursing required, out of which,</p> <p>1 year of experience in research nursing</p> <p>May substitute relevant clinical research experience for clinical nursing experience on one-on-one basis</p> <ul> <li>Preferred </li></ul> <p>Phlebotomy experience.</p> <p>Experience with injections (subcutaneous, intravenous and intramuscular).</p> <p>Licenses and Certifications</p> <p>Graduate of NLN (National League for Nursing) approved Nursing program, licensure as Registered Nurse by Board of Nurse Examiners for the State of Texas Upon Hire and</p> <p>(BLS) BASIC LIFE SUPPORT certification through a course accredited by the American Heart Association (AHA) or American Red Cross (ARC) Upon Hire</p> <p>JOB DUTIES</p> <ul> <li> <p>Nursing:</p> </li><li> <p>Performs advanced nursing care, nursing assessment, and data collection for clinical research studies.</p> </li><li> <p>Provides working direction for research activities to nursing staff and/or other non-licensed medical or office support personnel.</p> </li><li> <p>Assists in resolving problems relating to patient care and acts as a liaison between the research team and other institutional stakeholders.</p> </li><li> <p>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.</p> </li><li> <p>Develops, implements and/or standardizes 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</p> </li><li> <p>Acts as a study-designated liaison in resolving problems relating to patient care and acts as a patient advocate.</p> </li><li> <p>Patient and study management:</p> </li><li> <p>Recruits patients for multiple and/or complex research studies ensuring subject eligibility, screens patients, tracks patients' data and explains the study purpose and content of each study.</p> </li><li> <p>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.</p> </li><li> <p>Obtains informed consent and follows the proper consenting process for patients and/or family members, per the protocol and IRB regulations</p> </li><li> <p>Monitors and evaluates patients involved in research studies within scope of practice, including their response to therapy or intervention.</p> </li><li> <p>May maintain or oversee inventory of investigational drugs, devices or approved medication for each protocol and acts as liaison between investigator and IDS pharmacy as each protocol requires, as per protocol requirements.</p> </li><li> <p>Data and regulatory management:</p> </li><li> <p>Trains 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.</p> </li><li> <p>May coordinate 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:</p> </li></ul> <p>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</p> <p>protocols. May also report information to other physicians and granting agencies.</p> <ul> <li> <p>May collect, label, store and/or ship blood, serum, urine, and other specimens for analysis per the protocol requirements.</p> </li><li> <p>Documents and updates the physician and sponsors on condition of the study participants including possible side effects of therapy.</p> </li><li> <p>May act as a study team liaison and provide direction in resolving queries from study sponsors or regulatory authorities.</p> </li><li> <p>Reports adverse events through appropriate sources per the policy of the protocol and the University Institutional Review Board (IRB) regulations.</p> </li><li> <p>May assist in organizing and preparing collected data for subsequent publication as appropriate.</p> </li><li> <p>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.</p> </li><li> <p>May respond to internal and/or external audit requests as a subject matter expert for assigned studies.</p> </li><li> <p>Occasionally, attends and participates in out-of-town meetings or scientific conferences as a representative of the research team, and attends and participates in meetings relating to clinic activities.</p> </li><li> <p>Performs other duties as assigned.</p> </li></ul> <p>SECURITY AND EEO STATEMENT</p> <p>Security</p> <p>This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.</p> <p>EEO</p> <p>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.</p>