Clinical Research Nurse Coordinator

5 days ago

Midlothian, Virginia, United States Bon Secours Mercy Health Full time
About the Role

We are seeking a highly skilled Clinical Research Nurse Coordinator to join our team at Bon Secours Mercy Health. As a key member of our research team, you will be responsible for coordinating and managing clinical trials, ensuring compliance with regulatory requirements, and providing exceptional patient care.

Key Responsibilities
  • Enroll patients in research studies, associate visits/appointments/admissions with research studies, and review 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 Cancer Institute, hospital departments, and sponsoring agencies for multiple 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.
  • 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 (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.
  • 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 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.
  • 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 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.
  • 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.
Requirements
  • BLS Basic Life Support – American Heart Association (required)
  • RN license current in Commonwealth of Virginia (required)
  • Bachelor of Science Nursing preferred); RN required
  • 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).
What We Offer

We offer a comprehensive benefits package, including 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.

We are an equal opportunity employer and welcome applications from diverse candidates. 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

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