Works at a clinical research site under the direction of a principal investigator or sub- investigator and reports to the Clinical Manager of Medical Oncology. All activities are conducted under Good Clinical Practice (GCP) Guidelines.
DUTIES AND RESPONSIBILITIES:
Follows all protocols for site preparation for a study.
Checks eligibility requirements to confirm patient eligibility for protocol.
Completes data compilation in a timely manner.
Provides follow-up and maintenance.
Ensures informed consent and all pre-treatment and eligibility requirements of protocols have been met prior to registration.
Enrolls/Registers protocol patients with the appropriate sponsor or statistical office.
Documents record of institutional patient registrations as well as data assigned by sponsor or statistical offices.
Orders and maintains investigational agents as provided by the protocol.
Practices good guest relations with patients, visitors, physicians, principal investigators, sub-investigators, pharmaceutical representatives (monitors) and staff, assists as needed.
Operates equipment safely and correctly.
Demonstrates awareness of the responsibilities of the position and how it interfaces with the rest of the healthcare team.
Works closely with all department members as required, is flexible to meet the needs of the department and changes in the workload.
Demonstrates an ability to be flexible, organized and function under stressful situations.
Maintains a good working relationship both within the department and with other departments.
Consults with other departments as appropriate to collaborate in patient care and performance improvement activities.
Participates in risk management and safety activities.
Documentation meets current standards and policies.
Consistently demonstrates a professional, self directed, mature, disciplined and tactful approach to department responsibilities
Attends necessary educational events, including weekly tumor boards.
Files protocols, SAEs and other documents with appropriate IRB.
Other projects as assigned.
Demonstrates the ability to deal with pressure to meet deadlines, to be accurate, and to handle constantly changing situations.
Demonstrates the ability to deal with a variety of people, deal with stressful situations, and handle conflict.
Adheres to dress code.
Completes annual educational requirements.
Maintains regulatory requirements.
Wears identification while on duty.
Maintains confidentiality at all times.
Attends department staff meetings as required within the department.
Reports to work on time and as scheduled; completes work in designated time.
Represents the organization in a positive and professional manner.
Actively participates in performance improvement and continuous quality improvement (CQI) activities.
Coordinates efforts in meeting regulatory compliance, federal, state and local regulations and standards
Communicates and complies with the Benefis Health System Mission, Vision and Values as well as the focus statement of the department.
Complies with Benefis Health System Organization Policies and Procedures.
Complies with Health and Safety Standards and Guidelines.
Ability to perform head-to-toe assessments on all patients and reassessments in compliance with the clinical research protocol.
Demonstrate an ability to assist physicians, principal investigator and sub-investigators with protocol-related procedures.
Demonstate an ability to be flexible, organized, detail-oriented, and function under stressful situations.
Knowledge of medications and their correct administration utilizing the clinical research protocol.
Follows protocol guidelines to ensure/reduce the potential of medication errors.
Performs all aspects of patient care in an environment that optimizes patient safety and reduces the likelihood of medical/health care errors and are in compliance with clinical research protocol.
Ability to interpret the results of waived tests; takes appropriate action on waived test results.
Treats patients and their families with respect and dignity.
Communicates appropriately and clearly to physicians, principal investigator, sub-investigators and staff and all others.
Demonstrates an ability to be flexible, organized and function under stressful stituations.
Documentation meets current standards and policies, including those governed by the FDA's Good Clinical Practices (GCP).
Consults with other departments as appropriate to collaborate in patient care and performance improvement activities with regard to patients' participation in a clinical trial
Current State Registered Nurse Licensure required; Bachelors Degree in nursing, business or health related field preferred.
Clinical Research experience preferred.
Ability to work with physicians, principal investigator, sub-investigators and others in a collaborative manner
Must complete and pass IATA training (this is a certificate for shipping and packaging specimens).
As a not-for-profit community health system, Benefis is driven to provide the highest level of care. We serve nearly 230,000 residents across a 15-county region that is bigger than Connecticut, Massachusetts, New Hampshire and Vermont combined. Benefis is the largest non-governmental employer in the Great Falls area, with more than 3,000 employees. Benefis has 530 licensed beds (that includes 146 beds in long-term care, 71 in assisted living and 20 beds at Peace Hospice of Montana) and partners with over 250 area physicians.
Our hospital has been recognized for its exceptional work in quality care by providing a wide range of programs and services to help you live the best life possible. We’re here to help you “Live well.”
Benefis Health System came about when two Christian-based hospitals became one. Our founders believed in providing good care to all in need, and trusted that this would be accomplished. The Benefis name was derived using Latin root words: "Bene-" meaning good, and "fis-" for faith and trust. It’s these same root words that make up such terms as ‘be...neficial’ and ‘confidence'. Benefis has been a trusted provider of care for more than 125 years. And our name speaks to our commitment: good care one can put faith in.
Benefis is consistently ranked among America’s top hospitals by the nation’s leading healthcare ratings organizations for a range of services, including cancer care, joint replacement, stroke treatment, wound care and home health.
To learn more about our services, continue looking through our website at WWW.BENEFIS.ORG or call 406.455.5000.