Additional Info
General Position Information
Position Number: 00089484 | Working Title: Clinical Study Nurse Coordinator |
Department Name: Int Med FPBCC Clin Trials Office UNMC | Reports To Title: Research Nurse Manager |
Position Description Details
Responsibilities and Duties
RESPONSIBILITY | TIME SPENT PERCENTAGE | ESSENTIAL FUNCTION | TASKS |
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Patient Care Management | 50 | | 1. Coordinate patient appointments, patient enrollment, recruit and screen patients for inclusion into study protocols and ensure the treatment provided and the data collected adheres to study protocol. (E) 2. Assess health status by interviewing patients regarding medical history, performing physical examination, and psychosocial assessment. (E) 3. Provide preliminary evaluation in consultation with physician at time of treatment decision and to determine final eligibility for enrollment into research protocol. (E) 4. Gather and review patient information (examples may include # medical records, radiology films, and pathology) from referring physician. (E) 5. Assess for insurance coverage and obtain insurance preapproval if required. (E) 6. Assist patient with travel arrangements, housing and orientation to Omaha and the University of Nebraska Medical Center. (E) 7. Assist with obtaining informed consent by explaining investigative trials, all tests and procedures to patient/family and address any questions/concerns. (E) 8. Provide in-depth description of clinical trial including purpose, treatment plan, potential risks, potential benefits, and financial obligations, and rights of the research subject. (E) 9. Provide overview and comparison of treatment options related to clinical trial vs. standard therapy.(E) 10. Responsible for coordination of research protocol and case management of patient while patient is participating in clinical trial. (E) 11. Prepare physician orders; coordinate all diagnostic tests and procedures relevant to the study and follow-up to ensure the orders are carried out. (E) 12. Test results are reviewed with investigator and acted upon as directed. (E) 13. Responsible for placing all records including signed informed consent in patient chart. (E) 14. Responsible for obtaining study lab samples, preparation, and possible shipment of specimen. (E) 15. Provide psychological support to patients and families. (E) 16. Facilitate communication between patient/family and interdisciplinary team and coordinate services related to patient care. (E) 17. Perform therapeutic procedures under the direction of the physician. Procedures may be dependent on research protocol. This may include but is not limited to infusing bone marrow or stem cells to patients following high dose chemotherapy and/or radioimmunotherapy, subcutaneous and intradermal injections, and drawing blood from central lines as required by the research protocols. (E) 18. Responsible for the randomization of patients to treatment arms. (E) 19. Responsible for monitoring patient health status during treatment. (E) 20. Assesses and manages symptoms/toxicities/health abnormalities related to disease or treatment in collaboration with physician, other allied health personnel, patient and family throughout the disease process: diagnosis, treatment, rehabilitation, palliative and terminal care. (E) 21. Responsible for entire research continuum from referral through short and/or long term follow-up and care of each patient as directed by the study protocol. (E) 22. Evaluate progress of research trial with the Principal Investigator and report results of research to staff. (E) 23. Collaborate with the Principal Investigator and interdisciplinary team to institute modifications to practice for improvement of patient outcomes. (E) 24. Meet with physicians, staff nurses, coordinators, P.A.#s, and other related personnel to explain new investigational trials, update ongoing trials or address any problems. (E) 25. Demonstrate knowledge and skill in addressing age specific needs of patients served, (all age groups-birth and above) (E) |
Research Protocol Management | 40 | | 1. Assist Principal Investigator by writing and submitting application and/or protocol to the IRB, SRC, Pharmacy and Therapeutics Committee, when new trials are initiated. (E) 2. Submit modifications to the protocol, IRB application, informed consents as needed during the course of the investigation. (E) 3. Prepare continuing reviews, internal and external adverse events and other reports to the IRB, SRC, FDA, and sponsoring agency as required. (E) 4. Responsible for coordinating and initiating research protocol with study sponsor, investigational pharmacy, nursing staff, and other UNMC departments affected by the research protocol and it#s requirements. (E) 5. Provide education to staff related to the protocol. (E) 6. Responsible for data collection including case report forms specific to study sponsor and/or institutional required data. (E) 7. Accurately interpret and record data to ensure that research results are error free. (E) 8. Maintain regulatory documentation as appropriate to meet federal and sponsoring agency guidelines. (E) 9. Develop data collection instruments (paper and computerized) as needed. (E) 10. Interpret, extract and record information from source documents and patient interview for support of clinical research. (E) 11. Provide reports to investigator and sponsor (listing and statistical) as requested. (E) 12. Collaborate with on campus data management and statistical team (Clinical Trials Office) to assist, when applicable, in the collection, interpretation, and analysis of the data. (E) 13. Collaborate with P.I. in preparation of publications and study results to include conducting library literature searches, evaluation and analysis of data and reporting of statistical information utilizing computerized techniques. (D) 14. Prepare estimated clinical budget for patient care costs related to each specific clinical trial for the purpose of final contract proposal. (D) 15. Assure charges are paid by study grant as appropriate by each study contract. (D) 16. Coordinate and manage UNMC sponsored multi-center trial for a particular research protocol. (E) 17. Manage all regulatory documents for participating sites, communicate with participating investigators and coordinators, drug accountability, gather and review external data, report to drug sponsor and FDA as required. This may include Cooperative Group Trials and Regional Group Trials established by UNMC physicians. (E) |
Other Responsibilities | 10 | | 1. Attend continuing education programs related to the clinical area. (D) 2. Reviews literature related to clinical area. (D) 3. Communicates advances in nursing practice or research care to other health care professionals through in-services, presentations and/or publications. (D) 4. Assure performance of behaviors that meet the requirements of the UNMC culture including: demonstrates behavior that fosters a positive team environment, demonstrates behaviors that promote diversity, applies continuous quality improvement principles, seeks the customers requirements and strives to meet them, and designs personal action plan for personal and professional development. (E) 5. Flexibility to assume new duties as the oncology program evolves. (E) 6. Other duties as assigned. (D) |
Zone Definition Factors
Impact
How quickly is the overall correctness of the work of an incumbent in this position typically determined?:
Determined within a relatively short period of time |
Include budget dollars, value of assets, and impact in terms of organizational exposure to risk/liability.
Describe the budgetary accountabilities for this position:
What impact do the decisions/recommendations made by the position have on the department/campus?:
Contacts and Communications
TYPE OF CONTACT | LEVEL OF CONTACT | FREQUENCY OF CONTACT | PURPOSE OF CONTACT |
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Entire disciplinary team at UMNC: Oncology/Hematology physicians, Tre | Internal to UNMC | Daily | For the purpose of coordinating patient care services |
Patients and their families | All Levels of Contact | Daily | For the purpose of explaining the investigational study, answering any questions regarding treatments, procedures, care and obtaining follow-up information on health status, and potential follow-up lab specimens required by protocol. Responsible for coordination of patient care and treatment during participation in a clinical research trial which includes the complex aspects of health care as it relates to treatment of malignancies. This includes inpatient and outpatient care, and encompasses the entire research continuum from referral of the patient through long-term follow-up and care. |
Insurance companies | External to UNMC | Weekly | For the purpose of assessing health care coverage, seeking preapproval for treatment and/or continued patient care updates |
Medical professionals and other allied health personnel outside of UNMC | External to UNMC | Weekly | For the purpose of coordinating patient care services |
Off-site investigative research teams participating in a multi-center trial, cooperative group | External to UNMC | Weekly | For the purpose of critical coordination and management of the complex decisions and regulatory requirements of each research protocol |
Sponsoring Agency | External to UNMC | Weekly | For the purpose of site initiation, discussing patient enrollment, answering questions, updating protocol, adverse event reporting, and setting up site visits for data review. Meet with study monitor on periodic visits to UNMC to review and gather data from case report forms. |
UNMC health care professionals | Internal to UNMC | Monthly | For the purpose of educating/informing them about a new clinical trial |
FDA inspectors, IRB and | All Levels of Contact | Monthly | For purpose of review and/or audit of study records and files |
Referring physician offices, UNMC physicians/departments, referring i | All Levels of Contact | Weekly | For the purpose of obtaining patient information, medical records, and provide information relating to treatment plans and continued medical care and may include maintenance of required regulatory documents. |
Supervision Received
Reports to Research Nurse Manager Susan Blumel, Direct, Daily |
Supervision Exercised
Does this position supervise?:
Type of Supervision Exercised:
Work Environment & Physical Demands
Working Environment
If Other/Combined Environment, please explain:
The full extent of the working environment TBD by position activities. |
Patient Care and Contact - Age Specific Competency
Check the appropriate box(es) that describes the Age Specific population(s) served within the scope of this position.
Activity Frequency
Sit: Continually (67-100%) | Bending: Occasionally (1-33%) |
Stand: Frequently (34-66%) | Kneeling: Occasionally (1-33%) |
Walk: Frequently (34-66%) | Reaching: Occasionally (1-33%) |
Drive Motor Vehicle: Not Required | Crawling: Occasionally (1-33%) |
Squatting: Occasionally (1-33%) | Climbing: Occasionally (1-33%) |
If other, please explain:
The full extent to TBD by position duties. |
Lift, Carry, Push, Pull Activity
Lift: Occasionally (1-33%)  41 - 60 lbs | Push: Occasionally (1-33%)  11 - 20 lbs |
Carry: Occasionally (1-33%)  10 lbs | Pull: Occasionally (1-33%)  41 - 60 lbs |
If other Lift, Carry, Push, Pull, please explain:
Full extent of lift/carry/push/pull TBD by position duties. |
Exposure
Animals (Category 1): NO | Moving Machinery: NO |
Animals (Category 3): NO | Biohazardous Material: YES |
Blood & Bloody Fluids: YES | Uncomfortable temperature/ humidity: NO |
Radiation/ Radioactive: YES | Noise: NO |
Chemical Hazards: NO | Working from Heights: NO |
Electrical Hazards: NO | Confined Space: NO |
3B or Class 4 Laser: NO | Dust and Dusty environments: NO |
Hot Work: NO | |
If other exposure, please explain:
Full extent of exposure TBD by position duties. |
Use of Protective Equipment
Hearing Protection: NO | Eye Protection: NO |
Half or Full Face Reusable Respirator: NO | Protective Clothing: YES |
If other protection, please explain:
Full extent of protective equipment TBD by position activities. |
Use of Hands/ Wrists
Keyboard: YES | Pipefitting: NO |
Fine Manipulation: YES | Grasping: YES |
Repetitive Motion: YES | |
If other use of hands/ wrists, please explain:
Full extent of hands/wrists TBD by position activities. |
Sensory
Ability to Speak: YES | Depth Perception: YES |
Hearing: YES | Distant Vision: YES |
Sight: YES | Near Vision: YES |
Color Vision: YES | Peripheral Vision: YES |
Emergency Conditions
During emergency conditions due to severe weather, natural disasters, major utility failures, or other unplanned events, certain personnel are activated to minimizethe impacts of emergencies and disasters, and to protect people, property, and restore the primary mission of the University of Nebraska Medical Center.These personnel occupy positions which are designated as 'Essential Positions.'
Essential: