A cover letter is required to be considered 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 the position.
The Clinical Research Coordinator is a vital member of the Transplant Research team who will help ensure that clinical research studies conducted at the Transplant Center are initiated and executed with the utmost quality, care, and compliance. To be successful in the position, the candidate must demonstrate exceptional organizational and problem solving skills, and possess uncompromising integrity. Applicants who desire a patient focused, team oriented, medically complex, scientifically interesting, intellectually stimulating, and fast paced work environment are encouraged to apply.
The Clinical Research Coordinator (CRC) will be responsible for the meticulous conduct of both interventional and observational clinical research studies, including pharmaceutical, industry sponsored trials, as well as investigator initiated research across multiple departments in Michigan Medicine. The CRC will work with patients in both the inpatient and outpatient settings, including both recipients and donors of solid organ transplants. The CRC must be able to simultaneously integrate the workflow for multiple studies, and will serve as a resource and contact person for active protocols. The CRC will be expected to facilitate communications between investigators, clinical staff, sponsors, contract research organizations, regulatory personnel, research patients, research support units, and study team members.
Other job responsibilities include:
Screening and enrollment of study patients;
Coordination and completion of study visits and laboratory procedures;
Distribution and accountability of study medications;
Preparation and maintenance of IRB submissions and other regulatory documents;
Timely and accurate entry of data;
Maintenance of studies in the OnCore clinical trial management system;
Creation and maintenance of source documents for tracking, collection and recording of experimental data;
Scheduling and completion of monitor visits, including timely completion of subsequent queries;
Review of proposed research, billing calendars, and study budgets for input regarding feasibility and effort requirements;
Creation of protocol summaries, checklists, workflow instructions, and other documentation to ensure proper and efficient study conduct;
Assistance with multi-site contracts, including Material Transfer Agreements and Data Use Agreements;
Attendance at educational, investigator, and coordinator meetings;
Maintenance of training, education, and knowledge regarding conduct of clinical research in accordance with federal and ICH GCP;
Participation in additional, paid, on-call shifts for evenings, nights, weekends and holidays is a requirement shared with co-workers.
Minimum undergraduate degree required, preferably in a health related field of study;
Minimum of 2 years of experience in clinical trial coordination;
Prior experience writing and maintaining IRB submissions, including initial applications, continuing reviews, amendments, and adverse events;
Proficiency in working with electronic medical records;
Knowledge of and experience with ethical and regulatory aspects of medical research and appropriate conduct of clinical trials, including The Code of Federal Regulations (CFR) and Good Clinical Practice (GCP);
Ability to communicate professionally and interact effectively with patients, faculty, staff, and others; team work is a critical component of this position;
Ability to work independently, think critically, prioritize, and exercise good judgement;
Proficiency with computers, specifically MS Word and Excel;
Desire to work in a fast paced, patient oriented environment to further scientific knowledge;
Positive attitude and desire to continually learn and grow professionally;
Availability to work some evenings, nights, weekends, and holidays to participate in the shared coverage of the on-call schedule necessitated by transplant organ availability; living within a 30-mile radius of the University of Michigan Hospital.
Advanced degree in nursing, clinical research administration, or other medical/research related field;
Four or more years of experience in medical research and clinical trial coordination;
Experience with both pharmaceutical clinical trials and investigator initiated protocols;
Demonstrated success working on multi-site research as both coordinating center and participating site;
Knowledge of Michigan Medicine policies and practice;
Familiarity with solid organ transplant patient care and terminology;
Experience with REDCap, iMedidata, or other data entry platforms;
Proficiency with collection and processing of laboratory specimens;
SOCRA or ACRP certification.
Coordinator work is currently being conducted remotely with occasional hours at the University Hospital;
Post-pandemic work will resume at the discretion of the University of Michigan Office of Research; primary location in UH South;
Normal work schedule is 8 a.m. to 4:30 p.m., Monday through Friday;
Participation in on-call schedule is required and additional pay is provided for one or more shifts per month that may include:
Weekday evening/night coverage of 4 p.m. to 8 a.m.;
Weekend coverage of 8 a.m. to 8 a.m. the following day;
Daytime coverage of holidays from 8 a.m. to 4 p.m.;
On-call work primary conducted remotely when possible, but may require presence at the hospital if transplant occurs outside of business hours and study requires in-person procedures.
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: 194038
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.