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 position will serve as a Clinical Research Coordinator Assistant in the Oncology Clinical Trial Support Unit (O-CTSU) - providing biospecimen processing and management support to faculty and research teams at the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

  • Excellent medical, dental and vision coverage effective on your very first day
  • 2:1 Match on retirement savings

Responsibilities*

Characteristic Duties and Responsibilities:

Knowledge of all 8 competency domains is expected:

  1. Scientific Concepts and Research Design
  2. Ethical Participant Safety Considerations
  3. Investigational Products Development and Regulation
  4. Clinical Study Operations (GCPs)
  5. Study and Site Management
  6. Data Management and Informatics
  7. Leadership and Professionalism
  8. Communication and Teamwork

Responsibilities will include, but are not limited to:

  • Clinic Coordination
    • Understands clinical research protocol structure, associated lab manuals, etc. and how to interpret study requirements to ensure compliance.
    • Assists with set up kits for research draws and perform quality checks.
    • Performs simple sample processing according to study documents.
    • Ships research samplers per protocol including coordinating with study sponsor's receiving sites via email or phone as required.
  • Data Coordination
    • Demonstrates the ability to complete simple data collection in recording sample disposition (freezer location or shipping tracker information).
    • Performs complete and accurate documentation on requisition forms, shipping documents, clinical trials management systems and other potential sponsor systems.
    • Checks own work and confirms accuracy.
  • Regulatory Coordination
    • Demonstrates familiarity with essential documents as described in the ICH-GCP guidelines.
    • Performs and records routine instrument maintenance procedures; (ex. temp logs, scraping freezers reviewing nitrogen supply, etc.)
    • Identifies and communicates protocol deviations and quality issues with unit leadership for assistance with resolution.
  • Administrative
    • May manage study supply inventory.
  • Training
    • Attending and participating in all training classes assigned to this level (Ex: PEERRS, HIPAA, CITI GCP).
    • Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.

Supervision Received:

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

Supervision Exercised:

None

Required Qualifications*

  • High School diploma or GED is necessary.

Desired Qualifications*

  • Associate 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.
  • Knowledge of university policies and procedures is desirable.

Work Schedule

  • Hours/Week:  40 hours
  • Shift as assigned to support unit operational hours Monday thru Friday from 7a-6p

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.

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 employment opportunity employer.