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

Bon Secours Mercy Health•Richmond, VA

2d•Onsite

About The Position

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. This role involves enrolling patients in research studies, managing clinical research projects, serving as a liaison between various entities involved in clinical trials, and ensuring adherence to study regulations and patient care standards. The position also includes managing regulatory documentation, patient recruitment, handling investigational products, providing direct patient care and education, and overseeing the close-out of clinical trials.

Requirements

5 years of nursing experience as an RN (required).
2 years of recent (within the last 3 years) research experience in a clinical setting (required).
BLS Basic Life Support – American Heart Association (required)
RN license current in Commonwealth of Virginia (required)
Bachelor of Science Nursing (preferred); RN required

Nice To Haves

Bachelor of Science Nursing

Responsibilities

Enroll patients in research studies, associating visits/appointments/admissions with research studies, and reviewing charges to determine billing to Insurance vs. 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.
Coordinate/plan patient recruitment, prepare inclusion/exclusion criteria checklist, prepare list of allowed and disallowed medications, and flow sheets.
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 CRFs, test results, and other documents as required and maintain copy per sponsor requirements.
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.
Work with Practice Manager to ensure all charges related to a serious adverse event are billed to the sponsor if the sponsor is paying for costs outside the scope of the original budget.
Participate in pre-site-qualification meetings, site selection meetings, interim monitoring visits, audits, investigator meetings, and complete all training required for each clinical trial.
Complete paperwork and submit initial protocols and consents to IRB for review.
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.
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.
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 chronic liver disease.
Review medical records pertaining to these patients and present to the attending physician group for review.
Review consent form with patients, including explaining how charges will be handled, and answers any questions.
Obtain patient’s signature on consent form.
Obtain required medical information from patients, advise patients of visits, assign numbers to the patients as required by protocol, and ensure that all study-related documentation, forms, CRFs, are complete before patient leaves the office.
Work closely with pharmacy on dispensation of investigational product, including having access to pharmacy system for each clinical trial.
Educate patients concerning natural history of chronic liver disease and its complications.
Educate patients concerning the side effects of specific medications and other treatment of chronic liver disease.
Complete study collection forms necessary to evaluate effects of treatment on chronic liver disease.
Answer phone questions for patients concerning possible side effects of the treatments they are receiving as well as complications associated with chronic liver disease or any other acute illness.
Assess this information and present to attending physicians within the Hepatology Section as appropriate.
Triage patient calls, arrange for appropriate care.
Arrange for special procedures for patients enrolled in clinical trials, including liver biopsies, ultrasounds, endoscopies, etc.
Administer fibroscan, EKG and breath ID tests as needed.
Collect medications from patients, inventory study drugs, return to sponsor.
Explain to patient how to follow-up for their care when study is completed.
If patient terminates study early - note the reason for file.
Complete all CRFs.
Complete all requests for corrections and return them to Sponsor.
Complete reports required by Sponsor and send final report to IRB.
Review regulatory binder, make sure all documents are present.
Store documents and inform Sponsor of storage location.