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 position will serve as a Clinical Subjects Coordinator in the Oncology Clinical Trial Support Unit (O-CTSU) providing regulatory support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers™. Help discover them.
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 filing, procuring, 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.
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: 196770
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.