The Department of Radiology is looking for an experienced highly motivated, organized, autonomous person with excellent multi-tasking ability to join our Radiology Research Team of 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.
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.
Project coordination and process development and management.
Experience with state or federal regulations.
Experience with protocol and policy adherence. Excellent customer service specifically building and maintaining relationships. Scheduling and managing appointments.
Ability to create study related materials for both staff and research volunteers.
Experience with auditing and reviewing records for compliance and quality of data.
Bachelor’s degree 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
8:30 – 5:00 pm
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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.
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