Under general supervision of a physician and nurse (if applicable), is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials. Collaborates with physician in determining eligibility of patients for clinical trials. Provides education to staff and patients. 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. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
ESSENTIAL DUTIES AND 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 protocol.
-Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
-In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
-Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
-Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
-Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
-May collaborate with Research Site Leader in the study selection process.
-Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors.
-Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
-May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
-May oversee 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.
-Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Associates degree in a clinical or scientific related discipline desired, Bachelor's degree preferred. Minimum three year experience in a clinical or scientific related discipline, preferably in oncology. SoCRA or ACRP certification preferred.
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.
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.
The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.