This is the entry level position on the Michigan Medicine CRC Career Ladder. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies. 

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

• Understands protocol structure and how to interpret study requirements to ensure study compliance.

• Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases.

• Demonstrates the ability to complete simple data collection during study visits 

• Enters data to complete forms (CRFs) on paper, databases, or Electronic Data capture (EDC).

• May administer minimal risk consents, surveys, and questionnaires.

• Performs simple study procedures with accuracy.

• Performs clerical duties, including, but not limited to, mailing and filing correspondence, calling patients and obtaining medical records. 

• May assist research coordinator in conduct of Site Initiation Visit (SIV); attends SIV

• May assist in and attends monitor visits and or audits.

• Ability to assist with regulatory aspect of clinical trial management.

• Prepare study procedure kits, shippers, CRFs, and requisition forms.

• Ability to work independently or as a member of a team

• Exceptional organizational and computer skills in Microsoft software applications.

• Ability to work with minimal supervision while maintaining productivity standards

• Demonstrated problem solving and conflict resolution skills.

• Ability to multi-task, work well under time constraints and meet deadlines. 

• Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.

• Perform other related duties as assigned.

• Understands importance of participant confidentiality and complies with HIPAA and U of M regulations

• Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants

• Is familiar with basic clinical lab equipment such as a centrifuge, freezers (various), pipettes, and standard 

• Laboratory safety requirements and guidelines.

• Other duties as assigned 

• High school diploma or GED is necessary. 

• 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. 
• Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available.
• Clinical experience with respiratory patients is highly desired.
• Certification through ACRP or SOCRA.
• 3+ Years of Clinical Research Experience.

M-F from 7:30 AM - 4:30 PM with some variability in start and end times depending on the needs of the clinical trial participants. Hybrid
 

Supervision Received:

This position receives direct supervision and reports directly to CRC-Project Manager.

Supervision Exercised:

None

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.

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 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.

The University of Michigan is an equal employment opportunity employer.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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