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Clinical Research Assistant

University of Michigan

Job Description

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.

Summary

The Clinical Research Assistant (CRA) position is a part of a Clinical Research Coordinator Career Ladder that offers upward mobility for professionals interested in clinical research and with the achievement of experience and qualifications.  The Section of Vascular Surgery is committed to supporting the career development and progression of the Clinical Research Assistant role, as it falls in line with the institutional career ladder.

The CRA will support the ongoing research and administrative functions within the Department of Surgery, Section of Vascular Surgery.  This position will provide administration support for multiple clinical research studies, which will include an understanding of study protocols to assist with successful implementation of all study requirements.  The CRA will interact with the Research Director, investigators, research staff, midlevel providers, and study participants and sponsors. 

Key attributes for the CRA role in the Section include ability to troubleshoot and problem-solve; demonstrate excellent interpersonal skills; strong attention to detail; effective written and verbal communication; and strong working relationships with stakeholders, Section Chief, Section Administrator, and Research Director. 

Mission Statement

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.

Responsibilities*

The CRA will provide support to the Research Director in the coordination and execution of human subjects clinical research projects within the Section of Vascular Surgery. Primary activities will include, but not limited to:

Clinical Coordinator Responsibilities

  • Demonstrate understanding of protocol elements/requirements and demonstrate the ability to execute simple study procedures
  • Demonstrate ability to screen participants for eligibility in industry sponsored clinical trials, NIH funded studies, and internal funded studies and enroll participants with accuracy
  • Assist in coordinating study visits or follow-up interactions, as well as schedule and assist with preparation for initiation meetings, monitor visits, and audits
  • Develop research procedures, case report forms, and recruitment materials
  • Act as a liaison between investigators, sponsors, clinical trials office, and other internal and external contacts for the initiation and execution of clinical research

Data Coordinator Responsibilities

  • Assist with data collection, data entry, and maintenance of all data related to patient participation in studies
  • Take an active role in ensuring data quality

Regulatory Responsibilities

  • Assist in preparation of Institutional Review Board submissions including the initial applications, as well as amendments and scheduled continue reviews, progress reports, safety reports, adverse events, and data use agreements
  • Collect essential documentation and maintain regulatory binders (CVs, MD licenses, IRB rosters, lab norms, etc.)

Administrative Responsibilities

  • Provide administrative support for study activity including scanning/filing of research documents; managing organization of research kits
  • Communicate with study participants via mail or email
  • Schedule subjects for research visits or follow-up appointments

Supervision Received

This position receives direct supervision and reports directly to the Section Administrator. 

Required Qualifications*

  • Associate Degree in Health Science or equivalent combination of related education and experience
  • Demonstrated understanding of medical terminology
  • Proficient in computer programs including word processing, spreadsheets, and databases

Desired Qualifications*

  • Bachelor’s Degree in Health Science or equivalent combination of related education and experience
  • Strong organization skills with attention to detail and willingness to learn new skills

Work Schedule

Flexible, Remote Work Opportunities:  This position will offer a flexible work schedule by offering both in-person and remote opportunities. The administrative work is primarily work from home.  However, the team strives to be in the office 2 days per week, which may need to be flexible on which days that is due to study demands and any potential patient recruitment in faculty clinics. 

Patient recruitment is currently a small part of this position, with most work being administrative work such as: query resolution; data entry; sponsors monitor visits; closing out monitor visits; opening and closing of clinical trials; and preparing and maintaining regulatory binders and patient logs.

When onsite, this CRA will have a dedicated office space (with door) that is among the Section of Vascular Surgery administrative suite and faculty offices.

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. 

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.


U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response website or the UM-Dearborn and UM-Flint websites.

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