Job Information
University of Michigan Clinical Research Assistant in Ann Arbor, Michigan
Clinical Research Assistant
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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 individual 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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .
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.
Job Detail
Job Opening ID
252265
Working Title
Clinical Research Assistant
Job Title
Clinical Research Assistant
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Hybrid
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Nonexempt
Organizational Group
Medical School
Department
MM Cardiac Surgery
Posting Begin/End Date
9/04/2024 - 9/11/2024
Career Interest
Research
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