Research - Laboratory/Non-Laboratory, Staff/Administrative
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
This position will serve as the Clinical Research Nurse Coordinator for the Cellular Therapies/Blood and Marrow transplantation. This position does not report to nursing. The candidate will be responsible for study coordination, education and operationalization for research patients. This includes educating patients and staff on possible side effects, 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 candidate is required to have a working knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
Coordinates clinical research studies with Study Coordinator-Data, ancillary services and clinical teams
Schedules Site Initiation Visits (SIV) meetings by sponsors/investigators
Attends workability meetings with a bedside nursing focus to review order sets for completeness and readability, IV pump & tubing requirements and to create fast fact sheet and education binder (treatment, possible side effects, and complications for the bedside nurse
Oversee & create the proper documentation for the infusion or side effects (dotphrase, etc)
Ensures research quality compliance including REMS training for the bedside nurse: Creates training material, train staff, administers test and tracks
Works with 7W/8E nursing leadership to coordinate education time for bedside nurses pertaining to just in time administration education, REMS training, etc.
Assist bedside nursing regarding medication administration and disposal
Track and record all current and upcoming research studies and reports at department quality meetings
Reviews dose changes or laboratory abnormalities under the direction of the MD’s to report on clinical trial
Orders study specific lab work and protocol specific procedures per study and department protocol/s
Works with research lab services to maintain lab supplies
Works with finance team regarding study and patient specific charges
Identify, screen, consent, enroll and track patients on clinical trials
Performs patient vital and phlebotomy (PK, PD sampling, EKG’s and other) as necessary
Attends investigator study meetings
Reviews budget and workflow of onboarding new clinical trials
Serves as a resource and contact person for active protocols
Partnered with study teams and advises sponsor of issues
Ensures scheduling aligns to protocol for study visits
Provides education to patients, families and significant others on research protocol requirements
Utilizes critical thinking skills to recognize and independently solve patient research barriers
Completes the nursing synopsis and FAST FACTs summaries utilized by nursing to manage and prevent barriers on the clinic unit floors.
Performs toxicity assessments, grading under the direction of investigator.
Participates in the review of research study data
Participates in quality assurance and in quality improvement processes
Possesses a working knowledge of clinical trial design and operation.
Demonstrates proficiency in operating multiple electronic applications used for documentation and obtaining results.
Provides study information by developing 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
Reviews study feasibility and protocol requirements in the research treatment plan 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, SOCRA, CITI or NIH Protection of Human Subjects Training Certification annually
Knowledge of current lab safety (including ICH and FDA) guidelines
Provides cross coverage to other research clinical coordinators
Maintains a highly professional and positive attitude
Other duties as required
The Research Nurse-Clinical Research Coordinator for BMT Program does not report to nursing and will have strong interpersonal and organizational skills with excellent attention to detail, ability to multi task and work well under tight timelines. The candidate will have excellent computer skills with proficiency in all Microsoft software applications and with MiChart/Epic. 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.
Current licensure as a Registered Nurse to practice in Michigan
Two to three years of experience caring for patient on Clinical Trials
2-3 years of oncology RN experience
1-3 years of BMT patient care experience
1- 3 years of Experience Coordinating Oncology Clinical Trials
Previous experience with Epic or MiChart
SOCRA or ACRP certification
Hours: 40 hrs., flexibility required. Shift: Day shift & some evening shift, hours will vary; Monday thru Friday, with a possibility of weekends and holidays
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 194195
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.