Research - Laboratory/Non-Laboratory, Staff/Administrative
A cover letter is required for consideration 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 this position.
This Oncology Clinical Trials Support Unit (O-CTSU) position provides human subjects research regulatory support to faculty members and research team members in the conduct of Rogel Cancer Center clinical trials research projects with various oncology programs.
Primary responsibilities include completing and submitting electronic Institutional Review Board (IRB) research applications to ensure compliance with University and Federal Government Regulations.
Adept skills with electronic document management and electronic document control are vital to success in this position.
Responsibilities: Maintain Regulatory Research records for several assigned oncology clinical trials.
Job specific tasks include:
Maintaining binders that document the history of the study
Writing and revising Informed Consent Documents that are presented to potential research subjects
Processing & submitting protocol amendments when the study changes
Creating SAE spreadsheets
Submitting SAE reports
Submitting DSMB reports and scheduled continuation renewals as well as study termination reports
This position will also be responsible for:
Signatures from Investigators and study team members
Collecting CV’s from Investigators
Obtaining associated paperwork and numeric values such as lab normal/CLIA,
Managing files (in hard copy and electronic) and maintaining copies of current paperwork such as updating regulatory documents information (i.e. updating 1572s financial disclosures, etc.)
Creating and organizing information to ensure accurate submission to obtain IRB approval
Gathering study renewal information from study team,
Attending program team meetings and participating as an actively engaged member of the Regulatory Team.
Bachelor's Degree or higher preferably in health science or health related field.
At least two years of experience coordinating clinical research or working in healthcare.
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
Excellent computer skills including proficiency in Microsoft software applications.
Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.
Willingness to be flexible in a dynamic working environment.
Ability to work with diverse teams of people in a diplomatic, collaborative and effective manner.
Clinical trials experience
Previous experience with Oncology research
SOCRA or ACRP certification
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.
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. 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.
Internal Number: 184260
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.