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.
The CSA will work closely with members of the Martin and Bielas Laboratories in sample processing, DNA isolation and storage, and management of the database. This position could include travel to off-site locations.
Assist study team with aspects of clinical research coordination including: identifying potential subjects, screening subjects, minimal risk consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
Collect specimens and monitor study subjects (children). Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).
Perform DNA isolation and prepare samples for shipment to sequencing centers.
Perform data management, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes.
Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.
In coordination with other CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures.
Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies 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 monitor visits.
Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.
Prepare and organize space for study related materials and equipment.
High School Diploma, Associates Degree or some college, or equivalent education and experience.
Candidates without additional experience and those who do not have a college degree should be aware that further education will be required for promotion.
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
Proficient computer skills including Microsoft software applications.
Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment.
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
Good attendance record.
Demonstrates understanding of clinical research.
Demonstrating understanding of some medical terminology
Experience working as a clinical research professional with children and their families.
Knowledge of UMHS policies and practice.
Familiarity with REDCap, OnCore, Epic, MiCHART, and eResearch applications.
PEERS, CITI, or NIH Protection of Human Subjects Training Certification.
Experience with local and central IRB application processes.
Shift/Hours: Primarily M-F days, however variability may be required by some projects including early mornings, evenings, nights, weekends and occasional travel.
Evidence of qualifications is provided by previous employment, references, performance evaluations, and/or personal interview
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a mnimum of seven days.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 197313
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.