Job Description

This position will independently provide study coordination for simple and moderately complex clinical research studies.  As a member of a coordination team, this position will help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.

The Inherited Cardiomyopathy Research Team consists of four physicians dedicated to working toward a common goal of providing the best possible care for patients with inherited cardiomyopathies. The teams' shared commitment to excellence, strong work ethic, and sense of unity results in high-quality research.  The team primarily focuses on industry sponsored novel clinical drug trials, but also participates in PI initiated studies and registries. The Inherited Cardiomyopathy Research Team is looking for a highly motivated, detail oriented, individual with a passion for research and patient care to join the team. 

*Please note this is not a laboratory tech position, and job duties do not include performing laboratory assays*

• Coordinate and execute sponsor and/or investigator-initiated clinical trials. 
• Attain in-depth understanding of study protocols and objectives to assist with successful implementation of all study procedures. Coordinate recruitment of patients for inherited cardiomyopathies trials and patient education relative to study participation.
• Perform medical chart review, patient screening, informed consent processes, scheduling and conducting patient study visits, data processing, and diagnostic and therapeutic interventions. 
• Directly interact with study patients in a clinical setting, acting as liaison between patients, investigators, nurses, other departments, sponsors, vendors, and regulatory agencies. 
• Manage patient research data accurately in an organized and timely manner; adverse event reporting; prepare appropriate reports for investigators and/or sponsors including maintaining and completing the supplied case report forms; project reports as required by study sponsors.
• Coordination and participation in site visits with the sponsor/CRO. Manage and coordinate data related to patient participation in studies, workflow as needed by multiple studies, and participate in maintaining regulatory files. 

This position requires excellent written and oral communication skills. To be successful in this position the self-motivated candidate should have a working knowledge of Good Clinical Practice (GCP), as well as governmental and local regulations governing clinical research.

The candidate must demonstrate strong interpersonal skills with exceptional attention to detail. A successful candidate will also possess strong critical thinking, and organizational skills. Candidates must be able to meet multiple concurrent deadlines independently. The candidate must demonstrate project management ability and a positive approach and capacity to accept feedback and use it to improve individual and team performance.  It is imperative in this position to be a proactive team member and be willing to assist other team members as needed.

Experience as part of a team with 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

Supervision Received: This position receives direct supervision and reports directly to a Faculty Principal Investigator.

Supervision Exercised: None.

Technician Level:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary. 
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs 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.  
• Candidate must possess proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and Adobe office products.

Assistant Level:

• High school diploma or GED is necessary. 

Technician Level:

• 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. 
• Previous experience with scheduling and project management.
• Certifications through ACRP or SoCRA are preferred but not required. Experience in scheduling appointments (in a clinical or non-clinical setting), using eResearch, EPIC (MiChart) and OnCore.

Assistant Level:

• 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. 

Work schedule will be Monday-Friday; 8a-4:30p

This position may be underfilled at the CRC-Assistant title based on selected candidates' qualifications.

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.

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 anytime after the minimum posting period has ended.

The University of Michigan is an equal opportunity/affirmative action 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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