Clinical Research RN

Clinical Research RN Bring your passion to Texas Health so we are Better + Together Work location: 8440 Walnut Hill Lane, Ste 220; Dallas, TX 75231 Work hours: Monday — Friday from 8am — 5pm Department highlights Strong team with strong, collaborative relationships Works closely with the Cardiovascular Structural Heart team Opportunity to innovate healthcare Qualifications Associate’s Degree in nursing required Bachelor’s degree in nursing preferred 6 months ICU/CCU/ER experience or equivalent required OR 2 years conducting clinical research (drug, devices, etc) required Clinical Research experience strongly preferred Research training via CITI (Human subject Protection and Good Clinical Practice) preferred Epic EMR, Realtime CTMS and SharePoint experience preferred Dangerous Shipping Goods/Materials Certificate preferred RN upon hire required ACLS upon hire preferred CPR within 30 days of hire and maintained every 2 years What You Will Do Conduct clinical studies according to FDA, CFR and ICH regulations and guidelines: from pre-study to startup to closeout. Including: Study Startup: coordination and facilitation of all departments and various organizations to successfully startup a study from feasibility to first. Be knowledgeable of the Sponsor’s protocol so that all study activities are completed correctly and completely. Train other site personnel, and medical staff, on the specifics of implementing assigned protocols; including the regulations and expectations of monitors. Educate participants, families and caregivers regarding protocol requirements and relationship to disease process. Communicate and meet with the Sponsors, IRBs, Physicians, regulatory bodies, etc. regarding essential study activities as necessary, such as the conduct of the study and review study data. Promote and represent the CRD in a positive manner. Develop and implement recruitment strategies for studies; which include screening potential study subjects according to the protocol’s inclusion and exclusion criteria. Be available to register participants after hours (on call 24 hours a day and on weekends). Schedule study subjects’ visits and during the study subject’s visit perform defined activities of the study completely and accurately. Complete the CRFs for the study accurately, completely, and in a timely fashion. Maintain adequate and accurate case histories for each study subject and record all observations in the source document during the study. Complete the adverse events source documentation for the sponsor and IRB for review by the Investigator. Including: Design and maintain organizational tools to conduct studies accurately and in compliance with GCP and ICH guidelines. Ensure the safety and welfare of the study subjects. Obtain proper written informed consent from each study subject prior to participating in the study. Maintain all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies) (ICH 1.51). Unless original copies are required to be kept by the Sponsor (i.e. EKG tracings, patient diaries, questionnaires, etc), then a note to file is placed in the study regulatory binder. Follows electronic source guidelines and certification and destruction of hard copies, when applicable. Including: Assign study subject numbers and maintain accurate and complete records of the receipt, administration, and return of all clinical supplies (including study drug). Assist in maintaining all required documentation in the study regulatory documentation file. Including processing and completing all IRB documentation. Including but not limited to: initial application, Informed Consent, modifications, amendments, Serious Adverse Events, advertisement, etc. Obtain and maintain certification through appropriate accrediting bodies: (RN, and BLS) As well as certification and training required for studies: GCP, HSP, etc. Additional perks of being a Texas Health Clinical Research RN Benefits include 401k, PTO, medical, dental, Paid Parental Leave, flex spending, tuition reimbursement, student Loan forgiveness as well as several other benefits. Delivery of high quality of patient care through nursing education, nursing research and innovations in nursing practice. Strong Unit Based Council (UBC). A supportive, team environment with outstanding opportunities for growth. Learn more about our culture, benefits, and recent awards. Do you still have questions or concerns? Feel free to email your questions to recruitment@texashealth.org. #J-18808-Ljbffr