Job Information
Bon Secours Mercy Health Registered Nurse Research Manager (RN) - Physician Office – St Francis Med Center in Midlothian, Virginia
At Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence.
Bon Secours
About Us
As a faith-based and patient-focused organization, Bon Secours exists to enhance the health and well-being of all people in mind, body and spirit through exceptional patient care. Success in this goal requires a culture of compassion, collaboration, excellence and respect. Bon Secours seeks people that are committed to our values of compassion, human dignity, integrity, service and stewardship to create an environment where associates want to work and help communities thrive.
Registered Nurse Research Manager (RN) - Physician Office – St Francis Med Center - Richmond, VA
Primary Function/General Purpose of 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.
Essential Job Functions :
Epic
- 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.
Project Management :
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 Cancer Institute, 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, FDA1572 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 cancer.
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 (ie, what tests are covered by study, which are standard of care and will be billed to insurance), 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, CRF’s, are complete before patient leaves the office.
Investigational Product (IP)
- Work closely with pharmacy on dispensation of investigational product, including having access to pharmacy system for each clinical trial.
Direct Patient Care
Educate patients concerning natural history of cancer and its complications. Educate patients concerning the side effects of specific medications and other treatment of cancer.
Complete study collection forms necessary to evaluate effects of treatment on cancer.
Answer phone questions for patients concerning possible side effects of the treatments they are receiving as well as complications associated with cancer or any other acute illness. Assess this information and present to attending physicians within the Cancer Institute as appropriate.
Triage patient calls, arrange for appropriate care.
Arrange for special procedures for patients enrolled in clinical trials, including biopsies, ultrasounds, endoscopies, etc.
Completion/Close-out of Clinical Trials:
As each study closes:
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
This document is not an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. Employees may be required to perform other job-related duties as required by their supervisor, subject to reasonable accommodation.
Licensing/Certification
List the name of AND the accrediting/licensing body for both required AND preferred registrations/certifications/licensures. Fully write out any acronyms. For each listing, please denote if required or preferred, considering a candidate at time of hire.
BLS Basic Life Support – American Heart Association (required)
RN license current in Commonwealth of Virginia (required)
Education
- Bachelor of Science Nursing preferred); RN required
Work Experience
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).
Many of our opportunities reward* your hard work with:
Comprehensive, affordable medical, dental and vision plans
Prescription drug coverage
Flexible spending accounts
Life insurance w/AD&D
Employer contributions to retirement savings plan when eligible
Paid time off
Educational Assistance
And much more
*Benefits offerings vary according to employment status
All applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health – Youngstown, Ohio or Bon Secours – Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employers, please email recruitment@mercy.com . If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com
Many of our opportunities reward* your hard work with:
Comprehensive, affordable medical, dental and vision plans
Prescription drug coverage
Flexible spending accounts
Life insurance w/AD&D
Employer contributions to retirement savings plan when eligible
Paid time off
Educational Assistance
And much more
*Benefits offerings vary according to employment status
All applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health – Youngstown, Ohio or Bon Secours – Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employers, please email recruitment@mercy.com . If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com