This position will serve as the Research Nurse for the Cancer Center - Clinic Research Group and will be part of the Oncology CTSU. The candidate will be responsible for study coordination and Nursing Responsibilities for patients on clinical trials in the Cancer Center. This includes educating patients and staff on possible side effects and research procedures, organizing data, participating and planning for the research meetings. Utilizes critical thinking skills to recognize and solve patient/participant problems. Utilizes the nursing process and nursing standards to prevent or manage actual/potential patient/research participant problems in the Oncology setting. Ensures screening scheduling and coordination of care of research participants is accomplished as written in the research study protocol. Facilitates and maintains full regulatory compliance. The Research Nurse is required to have a working knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
This job will involve outpatient and Inpatient studies and will require morning and evening hours.
- Coordinates clinical research studies with Study Coordinator-Data, ancillary services and clinical teams
- Supervises dose changes or laboratory abnormalities under the direction of the MD?s
- Orders study specific lab work and protocol specific procedures per study and department protocol/s
- Works with research lab services and DMs to maintain lab supplies
- Develops in-services for Infusion Clinic Nurses
- Works with finance team regarding study/pt. specific study charges
- Identifies, Screens, consents and enrolls patients on clinical trials
- Performs phlebotomy (PK, PD sampling, EKG?s and other) as necessary
- Attends investigator and coordinator meetings as applicable
- Integrates the workflow of many studies running simultaneously
- Serves as a resource and contact person for active protocols
- Along with study team, advises sponsor of inconsistencies, errors or any issues of concern that may be identified by a critique of sponsor?s protocol
- Ensures screening, scheduling, correct timing of study visits and coordination of care of research participants is accomplished as written in the research study.
- Educates patient/participants and their families to the purpose of clinical research.
- Provides education to patients, families and significant others specifically related to research protocol requirements and the cancer diagnosis.
- Educates staff about treatment, possible side effects, and complications.
- Utilizes critical thinking skills to recognize and solve patient/participant problems.
- Utilizes the nursing process and nursing standards to prevent or manage actual/potential patient/research participant problems in the oncology setting.
- May provide patient care for patients.
- Performs toxicity assessments, grading under the direction of investigator.
- Participates in the review of research study data both through internal and quality control/quality assurance and participates in quality improvement processes
- Possesses a working knowledge of clinical trial design and conduct.
- Demonstrates proficiency in operating multiple electronic applications used for documentation and obtaining results.
- Provides information and develops appropriate resource documents, patient diaries and tracking tools for the medical and nursing staff enabling the successful completion of procedures and collection of data as written in the research study plan.
- Is able to consistently gather data and follow protocols and/or department guidelines with guidance
- Participates in the research treatment plan by reviewing the overall structure, and requirements for each protocol with the principle investigator, or designee.
- Organizational management, including, but not limited to, timeliness in completing source documentation, reporting adverse drug experiences, managing workload and managing patient study files.
- Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
- Collaborates with medical staff to facilitate and optimize the care of the research patient.
- Maintains current PEERS, CITI or NIH Protection of Human Subjects Training Certification annually;
- Maintains knowledge of current ICH and FDA guidelines. Facilitates and maintains full regulatory compliance and working knowledge of protocol requirements and good clinical practices as set forth by federal regulations
- Provides coverage for Coordinators and Research Nurses in other Oncology disease groups
- Provides Inpatient Research Coverage when needed
- Provides coverage in Nuclear Medicine for Research studies
- Helps with study feasibility, budgets, via Oncology information and any other required information
- Maintains a highly professional and positive attitude
- Plans and Coordinates CRT and other team meetings and the information required for those meetings
- Other duties as required by Leadership
The Clinical Research Group Research Nurse will have strong interpersonal and organizational skills with excellent attention to detail, ability to multi task and work well under time constraints. The candidate will have excellent computer skills with proficiency in all Microsoft software applications. They will participate in the development of research goals and objectives by attending staff meetings, in-service programs, attending appropriate continuing education opportunities, staff development programs, as well as participating in Quality Improvement initiatives to support implementation of change.
- Educational Requirement: applicant must meet one of the following: Bachelor?s degree in nursing OR an associate degree or diploma in Nursing and a Master?s degree in Nursing
- Current licensure as a Registered Nurse to practice in Michigan
- 3 or more years of recent RN inpatient experience OR recent experience administering chemotherapy, biotherapy, immunotherapy
- 2 yrs of experience in Clinical trials or 2 yrs of experience in Hematology/Oncology
NOTE: In order to be considered for this position the applicant must have met or will have met all the required qualifications prior to the start date of employment.
RESUME REQUIRED (for both internal & external applicants):
You must attach a complete and accurate resume to be fully considered for this position.
- 1 or more year of Experience Coordinating Oncology Clinical Trials
- 2 yrs of Hematology/Oncology experience
- Previous experience with Epic or MiChart
- SOCRA or ACRP certification
Salary & Nursing Framework Level:
This UMPNC RN posting is posted under the Role-Specific Advancement Model (RSAM) as:
CCC- COMPETENT NE.
Actual RSAM LEVEL and salary will be determined at time of hire.
RSAM levels range from CCC-COMPETENT NE to CCC-EXPERT NE TO CCC-MASTERY NE or CCC-Mastery Plus NE.
Required qualifications must be met by the candidate in order to be interviewed and considered for the position. Posting may be filled after the initial 5-day posting period.
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