Clinical Research RN

Texas Health Resources•Dallas, TX

49d•Onsite

About The Position

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

Requirements

Associate’s Degree in nursing required
6 months ICU/CCU/ ER experience or equivalent required or
2 years conducting clinical research (drug, devices, etc) required
RN upon hire required
ACLS upon hire preferred
CPR within 30 days of hire and maintained every 2 years

Nice To Haves

Bachelor’s degree in nursing preferred
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

Responsibilities

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 information consent from each study subject prior to participate 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