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.

Characteristic Duties and Responsibilities:
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

Responsibilities:
The Allergy/Immunology research team at the University of Michigan is looking to expand our research capabilities. We are looking for a research associate to assist on a number of on-going trials, with more soon to start. We are looking for someone with excellent people skills, who enjoys working with others and making a difference in people's health and lives. Tasks will include calling research participants, data entry, scheduling team meetings, assisting research participants when they come in for visits, screening for new participants, and assistance on tasks that may arise. You will also gain valuable experience in conducting research trials, and gain multiple skills that can be used in the future.

 Conduct and oversight of clinical trials in allergy. 

• Responsibilities will include recruitment of subjects, maintenance of accurate source documentation as well as electronic data entry. 
• This job will also include working on regulatory aspects with the sponsor, local and central IRB's, and the CTSU.
• Duties include close monitoring of patients after receiving investigational product  
• Assist with the execution of industry sponsored clinical trials and NIH funded studies, including recruitment and retention of subjects, scheduling of procedures, obtaining informed consent, and collection of data.
• Communicate with patients to set up appointment dates and times, document these interactions electronically, and follow up on lab tests as directed by the PI.
• Perform study-specific tests in clinic or other designated research space in person
• Design work flow and develop quality assurance processes for study start up, execution and conduct. Maintain accurate research records and transcribe collected data onto study documents, forms, and electronic research databases.
• Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements.
• Assists with reviewing billing calendars.
• Reconcile research billing, payments and invoices and finance issues in concert with department grant managers and financial team.
• Assures compliance with protocols, adherence to good clinical practice guidelines, sponsor regulations, and all other federal, local, and University guidelines.
• Other duties as assigned or required for the research project.
• Act as liaison between patient, investigators, other departments, sponsors, vendors and regulatory agencies.

CRC 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) and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire.  
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. 
• Previous experience with subject recruitment and retention, and coordination and management of NIH studies and/or clinical trials required, minimum 3 years.
• Ability to work independently or as a member of a team.
• Certification of Good Clinical Practice Training required, such as CITI or Transcelerate.
• Demonstration of understanding of Medical Terminology.
• Exceptional organizational and computer skills in Microsoft software applications.
• Ability to work with minimal supervision with diverse teams of physicians, coordinators, collaborators, Institutional Review Board, and Office of Research and Sponsored Projects in a diplomatic, collaborative and effective manner.
• 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.

CRC 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.  

CRC Assistant

• High school diploma or GED is necessary. 
• Experience in a medical setting
• Previous experience with subject recruitment and retention, and coordination and management of clinical trials required.
• Experience in the regulatory aspect of clinical trial management.
• Ability to work independently or as a member of a team.
• Demonstration of understanding of Medical Terminology.
• 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.

CRC Associate

• 4+ years of direct related experience
• Previous experience with REDCAP or a similar clinical research database desired.

CRC 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. 

CRC 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
• 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.

Monday - Friday onsite

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

Supervision Received: This position reports directly to PI.

Supervision Exercised: None.
 

Michigan Medicine (or unit specific name) 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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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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