OverviewMINNESOTA ONCOLOGYThis position will support the Maple Grove and Coon Rapids Clinics
Responsibilities SCOPE:
Manages 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, understands the strategic and operational objectives of the research program, may performs high level financial work including budget oversight. Trains and promotes professional development of staff. 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 HIPAA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
- 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. Responsible for review of consents to ensure proper execution of the informed consent process for study subjects.
- Coordinates patient care in compliance with protocol requirements. Disburses investigational drug and provide patient teaching regarding administration and other patient educational needs. 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. Enters orders to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting Provide clinical services as required including patient assessments.
- Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel. Responsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physicians. May be responsible for the development of practice research budgets.
- Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participate in scheduling monitoring and auditing visits. Interacts with the monitors/auditors while onsite. Provide input in determining, and implementing improvements to policies/processes. Works with clinic staff to solve complex issues around patient trial participation. Develops SOPs in collaboration with research and clinical teams.
SALARY LEVEL:$85,000-125,000 annually
Qualifications Minimum Job Qualifications (Knowledge, Skills, & Abilities):Education/Training -- Graduate from an accredited program for nursing education required (BSN preferred)
- OCN, SoCRA or ACRP certification preferred
- Current licensure as a registered nurse in state of practice
- Current BLCS or ACLS certification required
Business Experience -- Minimum three years of nursing experience required, including one in oncology
- Experience in clinical research strongly preferred
Specialized Knowledge/Skills -- 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
- Strong ability multi-task
- Must have excellent communication skills
- Excellent time management skills
- Must have a strong interpersonal skills to be able to interact with multiple people on many different levels
- Must have a high level of attention to detail
- Must be able to work in a fast paced environment
- May be responsible for basic clinical assessments
Working Conditions: Traditional clinic environment
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.): Large percent of time performing computer based work is required.
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.
