Clinical Research Coordinator Associate

Michigan Medicine; Ann Arbor (MI); Hybrid; USD 60,000 - 90,000; Full time

Job summary

Michigan Medicine is seeking a Clinical Research Coordinator to support multiple clinical studies, perform study procedures under supervision, and ensure quality work across data management, regulatory tasks, and study operations.

The role requires a BS in Health Science, certification within six months, and at least two years of related experience; hybrid work options are available and the team emphasizes adherence to GCP, HIPAA, and ethical standards.

Qualifications

• Bachelor’s degree in Health Science or equivalent required.
• Certification through ACRP or SOCRA (CCRC/CCRP) or equivalent required; eligibility to register and certification within six months of hire.

Responsibilities

• Performs non-GCP related study management activities.
• Performs study procedures with minimal supervision.
• Schedules, assists with preparation for study initiation meetings, monitor visits and audits.
• Completes form submissions and regulatory reporting to external bodies such as FDA.

Skills

Clinical Research Coordination

GCP & Regulatory Compliance

Education

Bachelor's degree in Health Science

ACRP/SoCRA Certification or equivalent

Job description

Mission Statement

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 Summary

BASIC FUNCTION AND RESPONSIBILITY

This 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 Clinical Research Technician position 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 elevate 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

• 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

Responsibilities*

50% Clinical Coordinator Responsibilities ex.

• Performs non-GCP related study management activities
• Performs study procedures with minimal supervision
• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits

10% Regulatory Coordinator Responsibilities ex.

• Form completion and reporting to external governing bodies such as the FDA
• Demonstrating an understanding of the elements of subject safety, related documentation, and reporting

20% Data Coordinator Responsibilities:

• Enters data to complete forms.

10% Training:

• PEERRS, HIPAA, CITI GCP

10% Administrative Responsibilities:

• Creates documentation materials for studies

Required Qualifications*

• Bachelors 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.)

Why Join Michigan Medicine?

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

Modes of Work

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.

Background Screening

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.

Application Deadline

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 any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.