This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate and/or CRC-Senior position on the Michigan Medicine CRC Career Ladder is required. This position demonstrates the ability to lead study team members in the implementation of study related activities. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, develop, evaluate, lead, guide, mentor, and support.

The Division of Rheumatology Scleroderma team is looking for a highly motivated, self-starting Clinical Research lead to guide the clinical research team in managing clinical trials and observational studies for the program. In this role, you will be supporting a multidisciplinary team of researchers and healthcare professionals dedicated to advancing research and improving care for patients with scleroderma and its related complications. 

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 Coordinator Responsibilities:

• Demonstrates the ability to create and manage the logistics for a new clinical trial.
• Applies critical thinking and creative problem-solving skills in the development of new processes, procedures, tools, and training to enhance clinical research activities.
• Demonstrates the ability to evaluate a monitoring plan against protocol and relates the plan to study team members.
• Manage workloads and resources/procurement.
• Using available resources at the University, determines study site feasibility.
• Provides input on feasibility of new studies (workflow, resources, populations). Advises PI or clinical  research teams of inconsistencies, errors or any issues of concern that may result in non-compliance or logistic issues.
• Assesses study budget for staff resources.
• Proficient in study implementation.
• Knowledge of risk management strategies and principles.
• Responsible for workflow process and study planning.
• Develops tools and trainings to aid in the creation of study budgets and tracking of invoiceable items.
• Manage the research conduct at other sites if U of M is acting as a coordinating center for a multi-site study.
• Provide appropriate financial oversight and resource management.
• Develops processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
• Demonstrated expert knowledge of clinical research systems.
• Assist in writing and review of protocols.

Data Coordinator Responsibilities:

• Develops or contributes to the development of processes, tools, and trainings to ensure the accurate collection of data at the site level.
• Performs at the highest level of data management, including the monitoring of data collection and reporting to ensure compliance.
• Oversees study conduct by staff and ensures quality work is done.
• Reviews manuscripts/poster presentations/abstracts as appropriate.
• Proficient in data management and results reporting.
• Demonstrates ability to create and manage the logistics for a new clinical research trial.
• Responsible for implementing study assessment needs. 
• Knowledge of the roles and responsibility of the various stakeholders in clinical research.
• Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency.

Regulatory Coordinator Responsibilities:

• Performs internal audits and adjusts SOPs for the management of IPs according to FDA regulations and GCPs.
• Knowledge of fraud and misconduct identification, reporting, and management.
• Responsible for workflow process and study planning. 
• Facilitates internal and external audits. 
• Ensure study compliance Provides oversight and follows FDA- Good Clinical Practices (GCP) or OHRP guidance for clinical research. 
• Ensures ethical guidelines are reflected in SOPs by adapting any established procedures, processes, or workflows to reflect any new or updated regulations.
• Designs processes, tools, and trainings to guide study team members in the understanding, recognition, and documentation of subject protection and safety issues. 
• Proficient in regulatory and compliance matters.

Administrative Responsibilities:

• Provide administrative supervision of a team > 3 employees 
• Manage HR activities including conflict resolution and timesheet approvals. 
• Knowledge of management concepts of and effective training methods to manage risk and improve quality in conduct of a clinical research study. 
• Recruit and train appropriate personnel for clinical research
• Utilize staff performance metrics
• Knowledge of the principles and practices of leadership, management, and mentorship, and how to apply them within the working environment

Characteristic Duties and Responsibilities:
Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in 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 Faculty Principal Investigator. 

Supervision Exercised: Provides Functional and/or Administrative supervision of one (1) or more staff in titles within the CRC Career Ladder.

Lead/Senior

• CRC Governance Committee review and approval  
• 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 5 years 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.) 

Lead:

• Masters Degree in Health Science or an equivalent combination of related education and related experience is desirable. 
• 9+ years of direct related experience

Senior

• 9+ years of direct related experience

This position is onsite Monday-Friday. 

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-Senior title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

Michigan Medicine Division of Rheumatology 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.

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.