Clinical Research Coord Assoc (Term-Limited)

Job Summary

Collects and manages patient and laboratory data for clinical research projects. Assist in completing all patient research data with management; prepare appropriate documents for physicians and/or clinical trial team members. Manage and coordinate data related to patient participation in studies, and workflow as needed by multiple studies.  Once research forms are collected, enter the research and clinical information into the internal database in a timely manner. Has working knowledge and experience in own discipline. Ideal candidate will continue to build knowledge of the organization, processes, and customers for overall improvement in processes. Uses prescribed guidelines or policies to analyze and resolve problems. Receives a moderate level of guidance and direction. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. 

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.

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.

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

Responsibilities*

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

• Person is able to work and complete work as detailed in CCDI supplement award (Project/Grant # F076018 - ShortCode #020512) for a fixed 1-year duration (Jan25 -Dec25)
• Extract patient information from EHR using Emerse, Datadirect, manual extraction and enter into RedCap dataset. Have all necessary study documents available and ready for physicians and scientist.
• Analyze the data and create tables and figures for the upcoming project summary and manuscript. Work with clinical teams, physicians, MCTP team as needed for the study.
• Scan documents and other paperwork as necessary.
• Manage and annotate patients, events and samples in LIMS (Laboratory Information anagement System).
• Follow up with physicians/patients on patient status for the outcome database.
• Working in MiChart, LIMS, Excel, Word, and RedCap applications daily.?
• Use of EMERSE and Datadirect software. 

Supervision Received:

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

Supervision Exercised:

None

Required Qualifications*

• 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.) 
• Proficient in SAS software and R language
• Background in both laboratory and clinical research related to cancer. 
• Excellent organizational, multi-tasking and problem-solving ability, as well as the ability to work under pressure, re-prioritize tasks independently, and meet deadlines with high degree of accuracy
  Ability to maintain strict confidentiality.
• Strong written and verbal communication skills, excellent interpersonal skills, and attention to detail with strong follow-through skills.
• Demonstrated ability to work independently as well as cooperatively.
• Strong passion for ideas, learning, and knowledge and ability to adapt to changing needs.

Desired Qualifications*

• 4+ years of direct related experience
• Knowledge of University and Michigan Medicine Policies and Procedures
• Previous experience with IRB and other governing bodies. 

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.

Additional Information

This is a term-limited appointment ending in December 2025. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits.  This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct. 

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. 

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 anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.