Registered Nurse (RN) - Clinical Research - Oncology - St. Francis Cancer Center

Bon Secours Mercy Health•Greenville, SC

1d•Onsite

About The Position

Serve as RN Research (Exempt) Clinical Research Nurse Coordinator for Bon Secours Cancer Institute. This role involves managing clinical research studies, serving as a liaison between various departments and sponsoring agencies, and ensuring adherence to study regulations and patient care standards. The position requires meticulous data collection, reporting of adverse events, and participation in regulatory and audit processes. Additionally, the role includes direct patient care, educating patients about their condition and treatment, and managing investigational products.

Requirements

BLS Basic Life Support – American Heart Association (required)
RN license current (required)
2 years of nursing experience as an RN (required)
Oncology nursing experience required
All candidates must possess strong communications (electronic and verbal) skills due to the detailed tasks entailed.

Nice To Haves

Bachelor of Science Nursing preferred
Research experience (CCRP Research Certification) preferred
OCN Professional Research Nursing certification preferred

Responsibilities

Enroll patients in research studies, associating visits/appointments/admissions with research studies and reviewing charges.
Organize and monitor clinical research observational and data collection studies.
Serve as Liaison between Bon Secours Cancer Institute, area 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 Investigators 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 Research Manager to ensure all charges related to a serious adverse event are billed to the sponsor if applicable.
Participate in pre-site-qualification meetings, site selection meetings, interim monitoring visits, audits, investigator meetings, and complete all training required for each clinical trial.
Maintain regulatory binders with all required documents.
Complete paperwork for proper processing of charges, reviewing coding, and approving bills to ensure the correct funder is charged for care of patients enrolled in clinical trials.
Complete required CITI GCP and human subjects research training, maintaining active certifications on file.
Assist PI and Sub-Investigator(s) in identifying patients for possible eligibility for treatment protocols.
Work with patient service representatives to schedule appointments to 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 for review.
Review consent form with patients, explaining how charges will be handled, and answer 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.
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 Bon Secours Cancer Institute as appropriate.
Monitor and report test results as appropriate.
Document in Epic and sponsor designated EDC’s as appropriate, communicating observations and findings to PI and attending physicians.
Triage patient calls, arrange for appropriate care.
Arrange for special procedures for patients enrolled in clinical trials, including biopsies, ultrasounds, endoscopies, etc.
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.
Adheres to all Bon Secours Mercy Health rules, regulations, and polices.
Performs other duties as assigned.
Assists and supports other departments when needed.
Individuals in this position are required to exercise universal precautions, use personal protective equipment and devices, and learn the policies concerning infection control.