Clinical Research Coord Associate/ Technician/ Assistant

Clinical Research CoordinatorThis position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination and data entry 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 Michigan Answers? 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 escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.ResponsibilitiesCharacteristic duties and responsibilities:Independent knowledge, skills, and abilities within all 8 competency domains is expected:Scientific Concepts and Research DesignEthical Participant Safety ConsiderationsInvestigational Products Development and RegulationClinical Study Operations (GCPs)Study and Site ManagementData Management and InformaticsLeadership and ProfessionalismCommunication and TeamworkThis position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.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 Data. Examples of duties a successful candidate in this role will perform:Demonstrates the ability to document data in accordance with ALCOA-C principles.Explains how to utilize information from the EMR and study databases.Completes complex data collection during study visits.Demonstrates ability to resolve data queries.Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.Schedules, assists with preparation for, and attends study initiations meetings, monitor visits, and audits.Required QualificationsClinical Research Coordinator - AssociateBachelor'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 Professional (CCRP) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.Minimum of 2 years directly related experience in clinical research and clinical trials is necessary.Clinical Research Coordinator - TechnicianAssociate degree in health science or an equivalent combination of related education and experience is necessary.Minimum 1 year directly related experience in clinical research and clinical trials is necessary or an advanced degree in a health-related area 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.Clinical Research Coordinator - AssistantHigh School Diploma or GED is necessary.Desired QualificationsClinical Research Coordinator - Associate4+ years of direct related experience.Clinical Research Coordinator - TechnicianBachelor's 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.Clinical Research Coordinator - AssistantAssociate 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.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 day2:1 Match on retirement savingsModes of WorkPositions 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 ScheduleMonday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.Underfill StatementThis position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.Background ScreeningMichigan 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 DeadlineJob 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 StatementThe 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.