Clinical Research Manager jobs in Ann Arbor, MI

Summary

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.

Responsibilities*

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from previous job description is required.

Experience as part of a team with 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

Specific competencies include:

• Conduct/schedule study participant visits
• Identify eligible study subjects
• Obtain informed consents from study subjects
• Collect and process specimens collected from study subjects
• Assist with regulatory activities
• Coordinate, facilitate and conduct correct timing of study visits and procedures with patients and staff
• Enter participants research data into an electronic data entry system

The above statements are intended to describe the general nature and level of work to be performed and are not an exhaustive list of all associated responsibilities

Required Qualifications*

Clinical Research Technician

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• At least one of the following:
  • Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.) OR
  • An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. OR
  • Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Clinical Research Assistant

• High school diploma or GED is necessary.

Desired Qualifications*

Clinical Research Technician

• Bachelor's 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.
• Clinical patient experience preferred
• Medical Terminology proficiency
• Phlebotomy proficiency
• Experience using eResearch applications and OnCore
• Professional certification through ARCP (CCRC) or SOCRA (CCRP)

Clinical Research Assistant

• 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.
• Clinical patient experience preferred
• Medical Terminology proficiency
• Phlebotomy proficiency
• Experience using eResearch applications and OnCore
• Professional certification through ARCP (CCRC) or SOCRA (CCRP)

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

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.