The Department of Otolaryngology—Head and Neck Surgery is seeking an experienced, highly motivated, well organized Clinical Research Coordinator to join our research team. The Clinical Research Coordinator will work with principal investigators and other research team members to carry out a range of tasks associated with a variety of clinical research trials and clinical research studies.
Regulatory management including preparing Institutional Review Board (IRB) applications and renewals in eResearch and billing calendars, writing and revising informed consent documents, creating and maintaining Clinicaltrials.gov registrations and conducting monitoring visits.
Develop and maintain clinical research databases. Develop data collection tools. Maintain and report subject enrollment data to NIH and external sponsors as required.
Screen and consent subjects for clinical research protocols. Facilitate collection of clinical research data and specimens according to protocols. Arrange for subject testing and data collectionboth onsite and offsite. Interpret and abstract clinical data for research records.
Ensure that clinical trials follow Good Clinical Practice.
Perform general office and administrative duties related to research projects.
Other duties as assigned
Bachelor's degree in related field or equivalent experience
Two to five years of clinical research experience
Experience in regulatory aspects of medical research and policy/procedures in the conduct of clinical trials both at an institutional and federal level. Experience with regulatory document development and oversight.
Meticulous attention to detail, strong organizational skills, ability to prioritize and manage time and data are crucial skills for this position.
Must be able to work independently and as a team member.
Excellent verbal and written communication skills.
Excellent computer skills, must be proficient in the use of MS Word, Excel and database software.
Requires flexibility in daily/weekly work schedule to ensure proper protocol adherence, meeting compliance requirements, screening/consenting of new patients, and working with multiple principal investigators.
Reasonable knowledge of University policies and procedures.
Experience with MiChart and Oncore
ACRP or SOCRA certified
GCP certified; CITI and PEERRS
Experience in database development and management (including developing surveys using RedCap, Velos, etc).
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: 177072
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.