Clinical Research Assistant

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.

Job Summary

The University of Michigan Cardiometabolic Research Center is a newly established, first-of-its-kind research center with PIs Dr. Ambarish Pandey and Dr. Thomas Wang. The Centers mission is to optimize cardiometabolic health and reduce cardiovascular risk across the health system through a data science-driven, risk-based approach spanning six integrated cores: Population and Data Science, Phenotyping, Cardiometabolic Health Clinic and Clinical Trials, Health System Implementation, Industry and Academic Partnerships, and Training and Education. The Clinical Research Program Manager will serve as the operational backbone of this multidisciplinary clinical research enterprise, providing administrative and scientific coordination across active clinical trials, observational studies, and translational research initiatives. This individual will report directly to the co-PIs of the Cardiometabolic Center and will play a central role in building and sustaining the research infrastructure of the Center from the ground up.

Responsibilities*

• Assist with participant screening and recruitment for complex trials are multiple research studies at any given time.
• Conduct and document consent for participants in studies and develop consent plans and documents for participants.
• Independently correct and document incomplete, inaccurate, or missing data for more complex studies.
• Understand visit schedules, criteria, and protocol requirements for complex trials.
• Complete research protocol related tasks.
• Review and abstract information from medical records.
• Recruit and enroll participants in research studies.
• Enter data into case report forms and assist with maintenance of study level documentation.
• Assist with data queries and possible edits for accuracy.
• Compile data for regulatory requirements and/or deadlines for submissions.
• Maintain existing databases and ensure data integrity.
• Assist with collecting and processing of specimens following established protocols. 
• Perform QA/QC and data checks using various clinical trial databases.
• Assist with preparation of annual reports for IRB review.
• Build databases for new studies.
• Perform other duties as assigned. 

Knowledge of 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

Supervision Received: This position receives direct supervision and reports directly to the Laboratory Manager.

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, and knowledge of university policies and procedures is desirable. 
• Experience:
  • 2 years of experience with Associate?s degree
  • 1 year of experience with Bachelor?s degree
• Skills: 
  • Knowledge of applicable Federal and institutional regulations governing clinical research.
  • Knowledge of clinical research protocols.
  • Effective organizational skills and attention to detail.
  • Ability to follow and understand regulations for PHI.
  • Ability to work as a team.
  • Possess strong computer skills, good communication skills, and the ability to problem-solve. 
• Technical Knowledge: 
  • Ability to work with various statistics platforms and data capture systems.
• Compliance: 
  • Demonstrated knowledge of research ethics, human subjects protection, and institutional compliance requirements for federally funded and industry-sponsored clinical research.
     

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

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

This position is located in Ann Arbor, Michigan, within the Division of Cardiovascular Medicine at Michigan Medicine. The Clinical Research Program Manager will report directly to Dr. Ambarish Pandey (Director and Co-PI) and Dr. Thomas Wang (Co-PI) of the Cardiometabolic Center. Standard full-time hours apply (40 hours/week, Monday?Friday). Onsite presence is required given the nature of clinical research operations; some flexibility may be considered based on specific project needs and institutional policy.

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 Statement

The University of Michigan is an equal employment opportunity employer.