Cancer Research Nurse (RN)

UNC Health; Hendersonville (NC); Hybrid; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

UNC Health in North Carolina is seeking a Clinical Research Nurse (RN) to coordinate and deliver care for patients enrolled in clinical trials, ensuring compliance with FDA, GCP, IRB, and sponsor requirements. The role emphasizes patient safety, informed consent, data integrity, and collaboration with the study team.

The position is full-time with a hybrid work arrangement, requiring strong documentation and coordination across EPIC and Beacon platforms to support trial activities and billing

Qualifikationen

• Must be licensed to practice as a Registered Nurse in North Carolina or a compact state.
• Experience in ambulatory clinical research preferred.

Aufgaben

• Identify potential clinical trial patients and collaborate with physician investigator to enroll eligible patients.
• Ensure informed consent is obtained and documented per FDA/GCP regulations and policies.
• Document assessments and management in source documents and ensure data in CRFs is accurate and auditable.
• Coordinate biospecimen processing/shipping per protocol and IATA/institutional policies.
• Perform EPIC-based research tasks: study records, billing analyses, and Beacon-driven treatment plans.

Kenntnisse

Clinical trial coordination

Informed consent process

Regulatory compliance

Team collaboration

Ausbildung

Registered Nurse license (NC or compact state)

Tools

EPIC

Beacon

Jobbeschreibung

Description

Your passion belongs at UNC Health. Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North Carolina.

Your passion belongs at UNC Health. Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North Carolina.

Summary

The Clinical Research Nurse (RN) is responsible for providing and coordinating clinical care for patients enrolled in a clinical trial while adhering to all FDA, OHRP and GCP guidelines and regulations. This position has a central role in assuring participant safety, ongoing maintenance of informed consent, and integrity of protocol implementation, accuracy of data collection, data recording and follow up.

Responsibilities

• Identifies potential clinical trial patients and collaborates with the physician investigator to enroll eligible patients to clinical trials. Serves as a resource to the patient care team for the management of care of patients participating in clinical trials, ensuring compliance with protocol procedures, assessments, reporting requirements, and management of symptoms.
• Ensures the initial and ongoing consent process is performed and documented in compliance with FDA, International Conference on Harmonization Good Clinical Practice (GCP), institutional, sponsor, IRB, and other applicable regulations and policies. Ensure patient comprehension and safety during initial and ongoing clinical trial informed consent discussions. Counsels and teaches research participants about protocol participation, treatment, and side effects, medication compliance, and administration of investigational drugs.
• Documents assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol. Ensures that relevant data from the source document are abstracted and accurately recorded in the clinical trial case report forms and that every data point can be verified within the source document. Organizes charts as required by the sponsor or research group for audits. Collaborates with physician investigators, pharmacy, and other appropriate personnel to ensure proper use of and accountability for investigational drugs.
• Adheres to protocol guidelines for the collection, processing, and shipping of biospecimens and accurately enters data into the protocol specimen tracker. Complies with the International Air Transport Association and institutional policies for shipping of biological specimens.
• Ensures that all Research Coordinator responsibilities are completed in EPIC including but not limited to: creating and activating a study record, creating a billing coverage analysis for each study, associating a patient with a research study, linking research encounters to the study, reviewing charges for research patients to ensure Medicare billing compliance, and create treatment plans in Beacon for research patients corresponding to the protocol requirements.

PARDEE

Other Information

Hired applicants will be expected to acquire Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or Association of Clinical Research Professionals (ACRP) Certified Professional (ACRP-CP).

Required

• Must be licensed to practice as a Registered Nurse in the state of North Carolina or one of compact states.

Preferred

• Experience managing research pharmaceutical trials in ambulatory setting.

01.8320.1514

Job Details

• Legal Employer: Pardee - HCHC
• Entity: Pardee UNC Health Care
• Organization Unit: Pardee Cancer Research
• Work Type: Full Time
• Standard Hours Per Week: 40.00
• Work Assignment Type: Hybrid
• Work Schedule: Day Job
• Location of Job: PARDEECANCR
• Exempt From Overtime: Exempt: No

Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.