This clinical research coordinator (CRC) position has oversight of the clinical trials within Interventional Cardiology and will provide study coordination for multiple clinical research studies ranging from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

• Aide in the management of logistics for a new clinical trial.
• Oversee protocol elements/requirements and demonstrate the ability to execute study procedures.
• Applies critical thinking and creative problem-solving skills in the development of new processes, procedures, tools, and training to enhance clinical research activities.
• Prepare for and lead monitoring visits
• Anticipate and mitigate the potential for protocol non-compliance.
• Triages simple subject concerns and issues appropriately.
• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.
• Utilize information from the EMR and study databases.
• Completes complex data collection during study visits.
• Resolve data queries.
• Manage and report Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs) as appropriate 
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Complete IRB submissions, including amendments and continuing reviews.
• Maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Properly completes payment forms and pays participants accordingly

Independent knowledge, skills, and abilities within 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 reports directly to the Interventional Cardiology Clinical Research Manager.

Associate Level:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.   
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire.  (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. 
• Working knowledge of Good Clinical Practice (GCP), FDA regulations and Code of Federal Regulations (CFR); in addition, experience with the IRB application process and understanding of medical terminology. 
• Demonstrate project management ability, work well in a team setting as well as independently with the ability to exercise good judgment in setting priorities, resolving problems, applying policies and procedures, while maintaining confidentiality at all times. 
   

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.  

Associate Level:

• 4+ years of direct related experience

Technician Level:

• Bachelors 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. 

This is a full time position with working hours primarily Mon-Fri. You will be onsite at the main hospital in Ann Arbor.

This position may be underfilled at the CRC-Technician 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 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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