Clinical Research Coord Assoc

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 This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Brighton Center for Specialty Care providing study coordination support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 175 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development, and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them. 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 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 Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Clinic and will be located at the Brighton Center for Specialty Care (BCSC) in Brighton. The coordinator may sometimes have to come to the Ann Arbor location for training and to provide help when needed. Examples of duties a successful candidate in this role will perform: Clinical Research Coordinator - Associate Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures. Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance. Describes protocol structure and explains how to interpret study requirements to ensure study compliance. Demonstrates accurate implementation of protocol procedures. Explains and performs non-GCP-related study management activities. Performs study procedures with minimal supervision. Triages simple subject issues appropriately. Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.). Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines. Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing. Responsible for Research sample processing. Clinical Research Coordinator - Technician This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required. Performs moderately complex study procedures with accuracy. Triages simple subject concerns appropriately. Assess studies for execution and troubleshoots potential implementation issues. Completes simple to moderately complex data collection during study visits. May work with CTSUs to reconcile financial accounts for study participants. Assists with local quality control efforts. Responsible for Research sample processing. Clinical Research Assistant This Clinical Research Assistant position will provide assistance for multiple clinical research studies. 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 can apply their skills to a broad range of tasks, navigate available resources appropriately and effectively use all tools and job aids at their disposal. They also know where and how to identify appropriate resources and support and can discern when to elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use. Required Qualifications Clinical Research Coordinator - Associate Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience. 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. 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 qualifying experience prior to applying. Clinical Research Coordinator - Technician Associate Degree in Health Science or an equivalent combination of related education and experience is necessary. ONE of the following: Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying. 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. 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. Clinical Research Assistant High School Diploma or GED Desired Qualifications Clinical Research Coordinator - Associate 4+ years of direct related experience. Clinical Research Coordinator - Technician Bachelor's Degree; Health Science field preferred or related certification. Understanding of medical terminology. Experience in a large, complex, healthcare setting. Ability to effectively communicate with staff and faculty of all levels. Knowledge of University policies and procedures. Clinical Research Assistant Bachelor's Degree; Health Science field preferred or related certification. Understanding of medical terminology. Experience in a large, complex, healthcare setting. Ability to effectively communicate with staff and faculty of all levels. Knowledge of University policies and procedures. 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. Work Schedule Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care. Underfill Statement This position may be underfilled at the CRC-Technician title based on selected candidates' qualifications. 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. #J-18808-Ljbffr Michigan Medicine