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Description

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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 their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.