Clinical Research RN

Overview

This is a mid-level exempt position. Responsible for the screening, enrollment, and maintenance of patients on clinical trials. Duties include assuring protocol compliance for all patients on trial, participation in consent process, ongoing assessments for changes in condition and adverse events, accurate and timely documentation / data entry, responsible for education and training of other staff and patients, serves a liaison between departments to assure proper conduct of trials. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Responsibilities

Key Responsibilities

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
• Coordinates patient care in compliance with protocol requirements. Disburses investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
• Working independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care team. Responsible for billing compliance reviews protocol specific billing guides and submits billing information to appropriate personnel.
• Oversee subject recruitment and study enrollment to meet goals. Works with study team to determine effective strategies for promoting / recruiting research participants and retaining participants in long-term clinical trials. Collaborates with SRL in study selection process. Provide clinical services as required including patient assessments.
• Collects and maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in scheduling monitoring and auditing visits, as well as interacting with the monitors / auditors while onsite.
• Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research. Provide input in determining, and implementing improvements to policies / processes. Works with clinic staff to solve complex issues around patient trial participation. Serves as liaison between departments for proper conducting of trial.
• Reviews the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.

Qualifications

Minimum Job Qualifications (Knowledge, Skills, & Abilities) :

Education / Training -

Business Experience -

Specialized Knowledge / Skills -

Working Conditions :

Environment (Office, warehouse, etc.) -

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology / hematology clinic environment.

Physical Requirements (Lifting, standing, etc.) -

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.

This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)