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.
Job Summary
This individual will report directly to the Senior Project Manager in the Department of Cardiac Surgery. The selected candidate will assist with study recruitment, setup and removal of digital recording equipment, acquisition and transmission of study-related data, and requisite regulatory materials related to a federally funded grant.
Responsibilities*
Clinical Activities:
- Screen and recruit subjects in accordance with the study protocol
- Obtain subject (patient, provider) consent
- Consent new providers
- Set up and remove digital recording equipment after each operation
- Coordinate with the operative team to ensure digital recording equipment is positioned appropriately to ensure safety and recording of the operation
- Track phases of operation
- Trial and troubleshoot digital recording equipment set up
- Collect, review and document study-specific data using electronic data capture systems
- Upload and archive study-related data from recording equipment
- Submit data to Data Coordinating Center
- Follow Good Clinical Practice (GCP) guidelines to conduct Clinical Research
Research & Administrative Activity:
- Notify clinical team members of upcoming recording cases
- Notify study team of any study-related issues that arise
- Participate in study-related meetings and visits
- Ensure the appropriate consents are in place before each operation
- Handle data discrepancies
- Report adverse events and protocol deviations
- Prepare, review and maintain site-specific regulatory materials
- Maintain study regulatory books in a secure research cabinet/room
- Maintain organization of all study-related correspondences
- Storage and maintenance of digital recording equipment
- Open to project-related changes, trialing and troubleshooting sessions
- Review, edit, and assist in scientific writing
- Oversee ancillary research staff
Required Qualifications*
- Bachelor's degree in biomedical or health-related sciences
- Ability to work independently as well as cooperatively with other team members
- Ability to assume responsibility, meet data deadlines and maintain confidentiality
- Excellent organizational skills, and verbal and written communication skills
- Proficiency in computer skills, including Microsoft software applications as well as electronic databases
- Ability to multitask, be punctual and detail-oriented
- Ability to work within tight deadlines
- Maintain professional and technical knowledge
Desired Qualifications*
- Proficient in the management of regulatory documents including Institutional Review Board (IRB) submissions, study amendments, adverse event reporting, protocol deviation reporting, quality assurance, data query resolution, understanding of compliance issues with regard to human subject research
- Experience with Michigan Medicine e-Research, Michigan Medicine MiChart, electronic data entry and management
- Knowledge of medical terminology and prior experience working with patients and clinical care providers in a healthcare setting
- Prior clinical research experience
- National Certification (SOCRA or ACRP)
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.
Additional Information
The position may require occasional off-hours (e.g., evenings and weekends), extended hours to ensure the recording of study cases as well as advance protocol-related duties
Full-time position; Monday-Friday days
Location: Michigan Medicine, Frankel Cardiovascular Center
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 anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.