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 Department of Radiology is looking for an experienced highly motivated, organized, engaged and autonomous person with excellent multi-tasking abilities to join our Radiology Clinical Research Coordinators. The candidate will take the lead on multiple study projects, in all aspects of clinical research including, IRB and regulatory management, subject recruitment, enrolling and consenting participants and data collection. Ability to work within a well-established team oriented environment.
Assist study teams with all aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, data collection and management data for clinical research subjects.
Coordinates and Facilitates correct time of study visits and procedures with patients and clinic staff.
Under the direction of MD – orders study specific labs and or diagnostic procedures.
Follows up for any abnormal or unexpected findings.
Creates source documents for accurate tracking, collection and recording of research data.
Effectively communicates with research team and clinical staff to correct/prevent protocol deviations.
Attend investigator and or scientific meetings
Maintains PEERRS, or OHRP certification.
Adheres to Code of Federal Regulations (CFR), Good Clinical Practice and maintains knowledge of current ICH and CFR guidelines.
Provide backup coverage for other Radiology Coordinators.
Creates and maintains current regulatory binders and documents including but not limited to: delegation of authority logs and training logs.
Develop procedure manuals for each assigned study.
Reports AEs, SAEs and protocol deviations to sponsor and IRB according to study specific timelines.
Two years previous study coordinator experience.
Current ACRP or SoCRA certification or working towards certification.
Bachelor’s degree in a science or related health field, or equivalent education and experience.
Excellent interpersonal, oral and written communication skills.
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 judgement.
Ability to work independently with minimal supervision.
IRB/Regulatory experience including initial IRB submissions
Knowledge of UMHS policies and practice
Experience with OnCore, MiChart, and eResearch Applications.
Experience with database development and management
Monday thru Friday - 8:30 am - 5:00 pm
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.
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. The review and selection process may begin as early as the eighth day after posting. This opening 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: 180766
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.