Clinical Research Coord Inter

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. Job Summary This position will serve as a Clinical Research Coordinator Intermediate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Brighton Center for Specialty Care providing administrative study coordination and clinic 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 150 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. Responsibilities* 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 Ann Arbor location for training and to provide help when needed. Examples of duties a successful candidate in this role will perform: Performs study procedures with accuracy. Demonstrates ability to triage complex study concerns appropriately. Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently. Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles. Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines. Provide other administrative support for study activity including management of subject reimbursement and payments. Participates in training's specifically for maintaining certification as a Clinical Research Professional. Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study. Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes. Responsible for research sample processing. Required Qualifications* Bachelor's degree in Health Science or an equivalent combination of related education and 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. 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 ) Desired Qualifications* 6+ years of direct related experience. 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. This position is located in Brighton (BCSC). May have to come to Ann Arbor location for training or to provide help/coverage when needed. 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 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. 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