Management of clinical research studies including patient screening and enrollment; study medication accountability; database management; coordination of study visits, labs and procedures; documentation and communication with physicians, study coordinators and sponsors.
Create source documents for accurate tracking, collection, and recording of experimental data.
Coordinates the submission of clinical study materials to IRB and other regulatory agencies for approval.
Collects specimens and monitors subjects. Assists in the reporting of tests results.
Attend investigator and coordinator meetings.
Serve as a resource and contact person for active protocols.
Critique study protocols and assist with budget.
Bachelor’s degree or equivalent professional degree and documented 5 years’ clinical research experience.
Ability to communicate effectively and follow written and verbal instructions.
Demonstrate strong analytical and organizational skills, including high level accuracy and attention to detail while exercising good judgment.
Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects and meet/negotiate deadlines.
Ability to effectively work with diverse teams as well as independently.
Demonstrate efficient organizational skills and ability to effectively problems solve and implement solutions to improve processes.
Excellent interpersonal and conflict resolution skills.
Takes initiative in process improvement and functions in self-directed manner and demonstrated willingness to be flexible where needed.
Understanding of IRB and applicable regulatory guidelines.
Proficient use of computers and applications including Microsoft Word, Excel, PowerPoint, EndNote, Microsoft Access and SPSS.
Experience in clinical trials.
Knowledge of and experience with UMHS basic research, ULAM and UCUCA policies and procedures.
Prior experience with laboratory administration and finance.
University of Michigan Health System 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.
The University of Michigan Health System 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 anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
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.