Registered Nurse; RN), Clinical Research - Physician Office - Cancer Institute Medical Oncology

Position: Registered Nurse (RN), Clinical Research - Physician Office - Cancer Institute Medical Oncology
Primary Function/General Purpose of Position

Serve as RN Research (Exempt)
Clinical Research Nurse Coordinator for Bon Secours Cancer Institute.

Essential Job Functions :

* Enroll patients in research studies, associating visits / appointments / admissions with research studies 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 :

* 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 (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 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. 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 Research 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 :

* 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.

Patient Recruitment/Enrollment :

* 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 (ie, what tests are covered by study, which are standard of care and will be billed to insurance), 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, CRF's, are complete.

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 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…