The Clinical Research Coordinator (CRC) will provide a valuable service assisting faculty with study coordination of clinical trials and observational studies. The CRC will be available to assist with study coordinator activities such as screening, consenting, and enrolling subjects; collection and management of patient and laboratory data; IRB application preparation, and regulatory management. Additionally, the CRC will manage audits and monitoring visits, as well as other duties as needed. The position will likely include travel to off-site locations and some flexibility in schedule due to meetings and scheduled study activities.
Oversight of the recruitment, enrollment and retention of subjects
Develop and implement effective study recruitment strategies
Supervise the scheduling and screening of potential patients
Update and maintain IRB
Monitor study progress toward goals and modify resources as needed
Maintain all study essential documents including responsible completion of all case report forms and accurate source documentation
Act as a liaison between clinical research team and sponsor, as well as between patient, investigator, and regulatory agencies
Oversight and responsible for research billing payment, invoices and patient reimbursement/stipends for studies
Work with internal resources and sponsor to facilitate specimen collection
Work with other centers to coordinate ongoing large registries including: enrollment reports, providing query/missing data reports, training other centers on changes to the database
Create, update and maintain IRB applications (amendments, ORIOs, AEs)
Manage and maintain compliance with regulatory requirements and study protocols
Provide oversight of data collection to ensure compliance with protocol and data protection
Directly report any issues to the Principal Investigator and/or Program Manager and implement necessary actions to reconcile the issue
Meet and work with sponsor study monitors
Address and respond in a timely manner to sponsor queries, database completion and regulatory issues Team Supervision
Other duties as assigned by PI
Familiarity with RedCap and database building is desired
Preferably at least three years of human subject research experience at U-M
Preferably at least one-year experience with IRB initial application submissions and amendments at U-M
Knowledge of Good Clinical Practice and ICH regulatory guideline
Proficiency with Microsoft Office programs including PowerPoint and Excel
Demonstrated coordination, time management, communication skills and ability to work independently and as a team member
Demonstrated ability to build and maintain relationships with research teams including Principal Investigators
Ability to manage multiple priorities with proficiency
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: 195847
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.