Clinical Research Coord Assoc/Tech/Asst

This clinical research coordinator (CRC) position has oversight of the clinical trials within Interventional Cardiology and will provide study coordination for multiple clinical research studies ranging 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.
Clinical Study Operations - understanding protocol and properly executing study design including development of study material, screening and recruitment of participants, and regulatory aspects. Attend tumor board and research  relevant meetings. Assist with tissue/sample coordination, procurement and transport. Management of patient relationship and interaction, patient onboarding, and sample preparation for multi-omic analysis.
Communication, Coordination, and Teamwork- properly and professionally coordinating and communicating with all research and study team. Attend weekly ALK meetings. Perform screening and coordinate recruitment efforts with various key stakeholders to obtain specimens from both U- M and partnering institutions.
Conduct direct and professional interaction with study patients in a clinical and virtual setting and act as a liaison between patients, investigators, and laboratory team.
Data management- Manage patient research data accurately in an organized and timely manner. Responsibilities may include:
OnCore patient and clinical study registration and data management Create, code, and manage REDCap database housing for clinical data samples and coordinate non-PHI data   transfer into Benchling. Conduct data modeling exercises using REDCap, statistical software including SPSS, GraphPad Prism, Tableau Create, model, and update genomic sample database with multiple clinical/sequencing/drug testing overlapping variables Reporting, Publications, and Presentations - Assist with creating study/research related documents, graphics, and presentations for Initiative-wide use.
Presentation of clinical team recruitment, data, and study status at ALK team meetings.
Assist with miscellaneous tasks as required by research group including but not limited to visit itineraries and tours, abstracts, presentations, and publications.
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 the ALK Program Manager. 
Supervision Exercised: None
Associate Level:
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 SOCRAs definition of a Clinical Research Professional for qualifying experience prior to applying.) 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 Bachelors of Scientific Nursing with clinical experience 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.  Full-time working M-F with the requirement of flexibility for early morning and evening hours, occasional travel, and rare weekends. Will consider a 75-80% position for the right candidate.
This position may be underfilled at the CRC-Technician/Assistant title based on selected candidates qualifications.
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. 
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.
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 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.
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.
Connections working at University of Michigan - Ann Arbor