Scope: Under general supervision of a physician, 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. Management of patient schedule according to study protocol. -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. -Set-up lab kits for phlebotomy staff and ship study lab specimens per IATA and protocol requirements. -Collaborates with outside institutions and vendors for continuity of care. -Works with outside vendors for 3rd party billing. -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. -Identifies 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.
Minimum Qualifications: Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred.
-Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCP concepts. -Experience with computer data entry and database management. -Excellent written and oral communication skills. -Excellent organizational skills -Attention to details and accuracy -Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents. -Ability to work independently, organize, prioritize, and follow through with results. -Ability to solve practical problems and implement solutions.
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.
Category: Clinical *HEC *CB *N *M
Internal Number: MCKEA00877904
About US Oncology Network
The US Oncology Network believes local cancer care is better care. We empower the delivery of advanced integrated cancer care through our network of independent physicians who share expertise and resources to provide quality, value-based care close to home.
Our clinical and business support capabilities, expertise and industry-leading technologies keep local practices at the forefront of high quality, efficient care delivery while enabling practice success, quality of life and financial security for physicians.
- 25 years of oncology practice management expertise
- Leader in value-based cancer care with over 900 physicians participating in the Center for Medicaid and Medicare
- Innovation Oncology Care Model – one fourth of the entire population of physicians nationwide
- Over 1,400 affiliated physicians
- More than 450 cancer treatment center locations across the United States
- Over 995,000 patients treated annually