A Precision Health program focused on vascular diseases at the University of Michigan Medical School is seeking a highly motivated and experienced Clinical Research Coordinator to join our team. This is a multi-disciplinary collaboration across the medical campus with the primary appointment in the Department of Internal Medicine, Division of Cardiovascular Medicine at Michigan Medicine/University of Michigan. The selected individual will serve as the primary coordinator for the Michigan Medicine Arterial Dysplasia Precision Health Network including multi-center collaborations. This individual will be responsible for overseeing participant enrollment at the University of Michigan and across the United States through an online enrollment structure, participate in the biospecimen collection processes, and conduct data collection from participants and medical records.

Successful candidates will join a highly collaborative research team that values transformative science and outstanding patient care.

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.

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.

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Clinical Coordination Responsibilities

• Oversee research participant enrollment, conduct and document informed consent, implement in-person and online participant recruitment activities, facilitate biospecimen collections, and serve as the primary point of contact for study participants
• Lead enrollment tracking and progress monitoring across multiple sites
• Provide guidance and mentorship to students supporting participant-facing activities

Data Coordination Responsibilities

• Manage study-related REDCap electronic data capture projects
• Serve as the primary individual responsible for participant data collection, distribution of study surveys and questionnaires, and data abstraction from medical records
• Supervise a dedicated database manager, ensuring integrity, security, and quality control of research data

Regulatory Coordination Responsibilities

• Conduct research-related IRB tasks such as continuing reviews, ORIO reports, and study amendments
• Assure compliance with institutional, state, and federal policies and guidelines and protection of PHI
• Independently draft and submit regulatory documents and correspondence

Supervisory and Leadership Responsibilities

• Oversee, train, and supervise student research assistants and the database manager
• Establish accountability systems to ensure timely and accurate execution of all delegated tasks
• Act as the operational lead, liaising between the PI, research staff, and collaborators

Other Administrative Responsibilities and Trainings

• Independent knowledge, skills, and abilities within all 8 competency domains is expected:
• 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

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 a Faculty Principal Investigator.

Supervision Exercised: Provides functional supervision to temporary staff, student research assistants, and a database 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. 
• Experience coordinating IRB submissions and regulatory compliance
• Experience supervising students, trainees, or staff in a research setting

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.  

Assistant Level:

• High school diploma or GED is necessary. 

Associate Level:

• 4+ years of direct related experience
• Experience with REDCap or other electronic data capture systems
• Experience with biospecimen management for research
• Prior supervision of junior staff or students in clinical research
• Experience coordinating multi-site studies

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. 

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. 

This position is a 40-hour-a-week full-time position (8 hours a day, 5 days a week) starting between 8?10 am. Modes of work will be primarily onsite with potential opportunity to occasionally work remote.

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates qualifications.

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.

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.