The College of Pharmacy Clinical Pharmacy department is seeking a qualified candidate for the position of Clinical Study Coordinator to assist in in the conversion of datasets into the right structure for analysis using various computer models and to design batch processing routines to increase efficiencies within the current laboratory research workflow that will help to expedite generation of final reports.
Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.
Act as liaison between study team and sponsors, IRB, federal, state and university officials and other regulatory agencies, including clinicaltrials.gov, to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitoring visits
Assist study teams with aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
Prepare and organize space for study-related materials and equipment
Perform data management and results reporting, such as entering information into databases and Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collections, processing, shipping/packing, storing, labeling, tracking, etc.).
Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems and applying policies, procedures and methods, while maintaining the strictest of confidentiality at all times
Bachelor of Science or health field or equivalent education and experience
Completed or willingness to complete ACRP/SoCRA certification within 6 months of hire
Experience with organization of datasets
Experience with IRB submissions
Excellent interpersonal, oral and written communication skills with exceptional attention to detail, including interaction with patient subjects. Proficient computer skills including Microsoft
Demonstrated understanding of clinical research; including compliance
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 190421
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.