Clinical Research Coord Assoc/Tech/Asst (Hybrid)

Details

Posted: 10-May-24

Location: Ann Arbor, Michigan

Salary: Open

Categories:

Staff/Administrative

Internal Number: 248923

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range 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.

 

 

Supervision Received:

This position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.

 

Supervision Exercised:

None.

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 the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs.

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
 

The clinical research coordinator is responsible for all aspects of study administration including but not limited to the following:

• Regulatory maintenance (prepares, maintains, and manages regulatory applications and submissions; maintains study binder and records, manages study communications and follow-up including query resolution in a timely manner)
• Conducts necessary procedures for study closeouts
• Creation of research documents, presentations, and educational materials for patients, staff, and faculty Screening for potential research participants in both inpatient and outpatient settings
• Explaining research studies to potential subjects and their parents and obtaining informed consent and assent 
• Entering subject study enrollment as required by Michigan Medicine Placing research orders in Michart 
• Scheduling and coordinating research visits Coordinating with the Data Office for electronic medical record data capture. 
• Data collection and entry into electronic data capture systems (e.g. REDCap, DrugDEV)
• Reliable tracking of subjects to ensure subject retention necessary for high follow up rate 
• Demonstrates ability to identify Adverse Events, Serious Adverse Events, and ORIOs and to report these appropriately
• Financial tracking of patient visits to ensure proper billing for research subjects, as well as processing subject incentives through HSIP Compliance with protocols, Good Clinical Practice, and applicable federal, state, & institutional regulations 
• Takes an active role in data quality by completing data queries

Clinical Research Coordinator Associate:

• 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.  (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)  
   

Clinical Research Technician:

• 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 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.

Clinical Research Coordinator Associate:

• 4+ years of direct related experience

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 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. 

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This position may be underfilled at the CRC-Technician or CRC-Assistant titles 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.

 

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