Registered Nurse; RN — Clinical Research Nurse Coordinator — Liver Institute of Virginia at St. Mary's Hospital

Registered Nurse (RN) - Clinical Research Nurse Coordinator

Serve as RN Research (Exempt) Clinical Research Nurse Coordinator for Bon Secours Liver Institute of Richmond with occasional support during emergencies (if needed) of the Liver Institute of Hampton Roads research site.

Essential Job Functions:

• Enroll patients in research studies, associating visits/appointments/admissions with research studies (utilizing both reporting workbench report and within the patient chart), and reviewing charges via the Research Billing Report to determine which are billed to Insurance and which are billed to the research study.
• Review site feasibility surveys and assist with budget preparations for new research.
• Organize and monitor clinical research observational and data collection studies.
• Serve as Liaison between the Liver Institute of Virginia, hospital departments, and sponsoring agencies for multiple clinical trials. Serve as liaison with partner institutions for multi-center (national and international) clinical trials.
• Work with other Bon Secours health system departments participating in clinical research to ensure adherence to study regulations and adequate patient care.
• Set up and maintain process/procedures for ordering tests for patients enrolled in clinical trials (special billing mechanisms, etc).
• Coordinate/plan patient recruitment, prepare inclusion/exclusion criteria checklist, prepare list of allowed and disallowed medications, and flow sheets (if needed). Set up source document utilizing electronic Case Report Forms (eCRFs), protocol, schedule of visits and tests, and other materials to ensure proper recording of data.
• Routinely interact with physicians, coordinators, clinical trials sponsors, and other individuals / organizations participating in clinical trials regarding patient care and related issues
• Complete CRFs and other documents at the time data is collected or immediately after the data becomes available. Obtain physician investigator's signature on CRF's, test results, and other documents as required and maintain copy per sponsor requirements after sponsor has reviewed and taken original. Retain completed CRFs and regulatory documents for as long as required by sponsor.
• Review adverse events and other data with Physician Investigator and ensure that information regarding adverse events is noted in documentation as required. Report serious adverse events to the Sponsor and IRB within the required time frame. Ensure all records related to adverse events are maintained on file. If the sponsor is paying for costs outside the scope of the original budget for a serious adverse event which required hospitalization or additional testing, work with Practice Manager to ensure all charges related to the SAE are billed to the sponsor.
• Participate in pre-site-qualification meetings, site selection meetings, interim monitoring visits, audits, investigator meetings, and complete all training required for each clinical trial.

Human Subjects Research/IRB/Regulatory Administration:

• Complete paperwork and submit initial protocols and consents to IRB for review (ie protocol, investigator's brochure, FDA
  1572 or investigator's agreement, consent form, current CVs, advertising (if any), and IRB forms.
• Handle IRB submissions related to clinical research, work with Physician and Practice manager and Bon Secours health system administration for contract review. Supervise work of Clinical Research Assistant(s) and other clinical coordinators.
• When IRB approval is received, receive and maintain CRF books from sponsor, to be maintained by clinical research nurse.
• Maintain regulatory binders with all required documents.
• Complete paperwork for proper processing of charges, reviewing coding, and approving bills to ensure the correct grant is charged for care of patients enrolled in clinical trials.
• Complete required human subjects research training and keep certification on file.

Patient Recruitment/Enrollment:

• Assist PI and Sub-Investigator(s) in identifying patients for possible eligibility for treatment protocols.
• Schedule appointments and evaluate patients for eligibility to participate in various programs to treat…