Clinical Trials Nurse, Neurology

y the CommonSpirit Health Research Institute. The incumbent has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise. The incumbent serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of practice. In conjunction with the PI and other facility/clinic staff, s/he may provide direct patient care related to a research protocol.

Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of

Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.

Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.

Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy.

In conjunction with the PI and other facility/clinic staff, may provide direct patient care related to the research protocol.

document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.

schedule participant appointments with appropriate provider/facility.

Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or CommonSpirit Health.

Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Graduate of an accredited school of Nursing required; OR Current RN license and Bachelor's degree, preferably in a science or health-related field, required.

Current California RN license required.

Minimum of 3 years of nursing experience with patients in a healthcare setting required, preferably in relevant clinical area (e.g., cardiology, oncology, neurology).

Minimum 3 years of experience conducting clinical trials required; worked as primary research nurse for at least 5 drug or device trials.

Experience in implementation of research protocols and clinical trials processes required.

Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.

Eligibility to sit for the exam within one year of hire or Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.

Current certificate of Human Subjects Protection and Good Clinical Practice training required.

CommonSpirit Health is an Equal Opportunity/Affirmative Action employer committed to a diverse and inclusive workforce. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, parental status, ancestry, veteran status, genetic information, or any other characteristic protected by law. CommonSpirit Health will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Qualified applicants with an arrest and/or conviction will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, ban the box laws, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances. If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at View phone number on click.appcast.io and let us know the nature of your request. We will only respond to messages left that involve a request for a reasonable accommodation in the application process. We will accommodate the needs of any qualified candidate who requests a reasonable accommodation under the Americans with Disabilities Act (ADA). CommonSpirit Health participates in E-Verify.