This position will be responsible for cellular immunotherapies clinical research trials. This position will lead, plan, coordinate and implement clinical research protocols for the Cellular Therapy Program.
Will include, but are not limited, to the following activities:
Lead in identifying potential protocol patients for clinical research trials. Coordinate the screening and scheduling of patients on study, perform patient phone assessments, track patient participation and conduct patient long-term follow-up assessments -Work with patients to evaluate the progression of their disease via trial specific assessments and collect data points based on evaluation
Identify, organize and train the appropriate clinical team members who will be involved in execution parts of the protocol-
Be a resource to investigator and clinical staff to work out study start up issues, logistics and communication related to trial requirements
Responsible for reporting AE/SAE’s to FDA, in addition to trial sponsors & various data bases
Manage logistics and coordination of patient care between the University of Michigan and outside institutions/sponsors involved in Cellular Therapy research protocols
Train new team members, other collaborating research teams, and ancillary members regarding Cellular Therapy’s research protocols and the research process by implementing Good Clinical Practices (GPC)
Timely written/verbal communication to Cellular Therapy’s study team and PI on the process of each trial assigned under their lead
Facilitate coordination and serve as lead liaison between other services (e.g. Research Pharmacy, CRAO, MICHAR, Cancer Center, Oncology CTSU, other research teams, etc.)
Prepare regulatory documents for PI-Initiated clinical research trials when necessary
Participate in the development of trial budgets with Principal Investigator (PI) and Cellular Therapy/BMT leadership
Provide annual review of research practices and guidelines that pertain to FACT
Assist in data collection and organization of the Cellular Therapy database
Participate in research meetings and interact with clinical and research staff from various departments involved in delivering care, implementation of trial and representation of the Cellular Therapy program
Participate in data management for trial as needed
Facilitate and maintain full regulatory compliance of all research protocols
Promote clinical trial skill development among team members
Minimum of a Bachelor's Degree in health or life science or significant experience (minimum 3 years) leading research trials
Excellent ability to interact with research patients, and take lead role in research trials
Ability to organize, prioritize and delegate effectively and efficiently
Ability to promote research trials and represent the Cellular Therapy program to other research teams within the University of Michigan or external medical teams
Blood/Marrow Transplant and/or immunotherapies experience is highly desirable
Strong project management skills and working knowledge in OnCore and Clinical trials.gov
Experience working with treatment research protocols
Experience working with both pediatric and adult patients and their families
Experience with UMHS MiChart electronic medical record
Excellent interpersonal and organizational skills
Reasonable knowledge of University research policies, confidentiality, and PHI rules
BSN nursing degree (minimum 5 years’ experience)
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. This job may be removed from posting boards and filled any time after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 181153
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.