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 the Clinical Research Coordinator for the Oncology CTSU - Clinic Research Group in the Cancer Center. The candidate will be responsible for study coordination for patients on clinical trials in the Cancer Center.
Provide data management and regulatory support for the conduct of LAPs /NCTN Cooperative Group clinical trials at the University of Michigan working with multiple teams, to collect and submit quality data on patients participating in NCTC Cooperative Group trials in a timely fashion.
Ascertain whether pretreatment and eligibility requirements are met, register patients to trials, abstract patient data from the medical record (including MiChart) and other sources onto electronic case report forms for online submission, collect and submit pathology slide tissue blocks, fax data forms and CRF’s not available for online submission.
Meet data submission timeline expectations, and respond to data queries from the NCTN Cooperative Group statistical center in a prompt fashion.
Work closely with physicians, physician extenders, research nurses and pharmacists for the study startup and maintenance.
Attend biweekly or monthly research meetings to monitor for patients on-study safety and accrual trials.
Work with research nurses to assure that the study calendar is followed with regards to study visits and form completion.
Screen all adverse events for seriousness and review adverse reports and report events to the IRB as well as the NCTN Cooperative Group.
Maintain familiarity with NCI and FDA guidelines for adverse event reporting. Assist the local physician investigators in submitting new NCTN Cooperative group studies to the IRB via e-research.
Provide maintenance of regulatory files for amendments and revisions, tracking data and protocol compliance monitoring and communicating effectively with the IRB via E-research.
Assure that NCTN Cooperative Group clinical trials are conducted in compliance with GOP and ICH guidelines.
Other responsibilities include: prepare for audits attending yearly NCTN Cooperative Group conferences, participate in NCTN Cooperative Group sponsored CRA training both online and at meetings.
Bachelor’s Degree in a health science discipline or equivalent combination of education and experience required.
Three to five years’ previous experience in the conduct of clinical research including IRB applications.
Critical to have good communication skills, be personable and relate well with study team members, be well organized, attentive to details, motivated to learn, and capable of multitasking and working independently.
Basic computer skills are required and experience in extracting information from electronic medical records would be useful.
Must understand issues with regards to human subjects research.
Previous experience with Epic, MiChart, Oncology research
SOCRA or ACRP certification
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 will be performed in compliance with the Fair Credit Reporting 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: 180792
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.