How to Apply
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.
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your very first day
- Retirement Savings Opportunities
- Provide data management and regulatory support for the conduct of LAPs /NCTN Cooperative Group clinical trials at the University of Michigan working with the Breast, Melanoma and Multiple Myeloma teams, to collect and submit quality data on patients participating in NCTN Cooperative Group clinical 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.
- Master's Degree
- 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.
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.