How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Summary
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-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC 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, demonstrate, develop, guide, and support.
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*
Expert level 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:
- Assist with aspects of inpatient trial coordination including screening, collecting, and managing patients and laboratory data for clinical research subjects.
- Prepare IRB submissions including initial as well as scheduled continuing reviews, progress reports, adverse event and ORIO reports and become subject matter experts for both local and external IRB submissions.
- Work collaboratively with the MCTSU finance team providing consultation on budget specifications and billing calendar creation, collaborate on post-award account reconciliation and close out.
- Provide support for FDA audits.
- Support other clinical research staff across the inpatient realm in study coordination activities during `off hours? and weekends.
This position should be able to perform tasks independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all of 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.
Supervision Received:
This position reports directly to the Associate Director for Inpatient Research.
Supervision Exercised:
Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.
Required Qualifications*
Associate Specific:
- 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 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.
Technician Specific:
- Associate's 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.
Desired Qualifications*
- 6+ years of direct related experience
- Demonstrated knowledge of medical terminology specifically related to inpatient research.
- Familiarity with EMR and research applications.
- Experience with IRB application process.
- Demonstrated understanding of clinical research; understand compliance issues related to human subject research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations.
- PEERS, CITI, or NIH Protection of Human Subjects Training Certification.
- Strong organizational skills required, ability to multi-task, and excellent written and verbal communication skills.
Work Schedule
This is a full time, 5-day work week, 40-hour work week position. Days of work include: primarily Monday through Friday, however some inpatient studies will require after hours and weekend work. Variability/flexibility will be required. Ability to work both from home and on site will be required.
Work Locations
MM Research-Clin Trial Units 1500 E. Medical Center Dr Ann Arbor MI 48109-5934
Underfill Statement
This position may be underfilled at the CRC-Technician based on selected candidate's qualifications.
Additional Information
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.