Job Summary
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
Responsibilities*
Characteristic Duties and Responsibilities:
Experience as part of a team with all 8 competency domains is expected:
Scientific Concepts and Research Design
Ethical Participant Safety Considerations
Investigational Products Development and Regulation
Clinical Study Operations (GCPs)
Study and Site Management
Data Management and Informatics
Leadership and Professionalism
Communication and Teamwork
Required Qualifications*
Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
or
An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
or
Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.Prior experience collecting and maintaining regulatory documentation;
Proficiency in working with electronic medical records;
Knowledge of and experience with ethical and regulatory aspects of medical research and appropriate conduct of clinical trials, including The Code of Federal Regulations (CFR) and Good Clinical Practice (GCP);
Ability to create source documents, to track protocol-required data points;
Ability to communicate professionally and interact effectively with patients, faculty, staff, and others; team-work is a critical component of this position;
Ability to train others in protocol-required tasks. This could include other coordinators, nursing staff, MAs, etc;
Ability to work independently, think critically, prioritize, and exercise good judgement;
Experience in surgical oncology studies;
- Proficiency with computers, specifically MS Word and Excel;
- Desire to work in a fast paced, patient oriented environment to further scientific knowledge;
- Positive attitude and desire to continually learn and grow professionally.
Desired Qualifications*
Bachelorss degree in Health Science or an equivalent combination of related education and experience is desirable.
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Work Schedule
Standard schedule is Monday - Friday 8AM-4:30PM. However, flexibility is expected and required based on patient schedule and meetings.
Work Locations
Coordinator work is currently being conducted in a hybrid model with a mixture of remote and on-site work as needed to perform the requirements of the role while maintaining high quality and service level to principal investigators and patients
Onsite work occurs at Taubman Center, Cancer Center, OR's
Additional Information
Supervision Received:
This position receives direct supervision and reports directly to the Director of Clinical Operations for the Department of Surgery.
Supervision Exercised:
None.
Background Screening
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.
Application Deadline
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 any time after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.