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Clinical Subjects Coordinator

Company: University Of Michigan
Location: Ann Arbor
Posted on: November 22, 2021

Job Description:

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 position will serve as a Clinical Subjects Coordinator 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 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 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. People want MichiganAnswers---. Help discover them. 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* * Assist study teams with all aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects. * Coordinates and facilitates correct timing of study visits and procedures with patients and clinic staff. * Under direction of MD- orders study specific lab work and diagnostic procedures. Follows up for abnormal or unexpected findings. * May perform ECG or other procedures as needed. * Works with research lab services and staff to maintain lab supplies and process samples. * Creates source documents for accurate tracking, collection, and recording of experimental data. * Accurately collect, maintain, complete electronic and paper case report forms and manage patient and laboratory data for clinical research projects. Will work closely with study monitors and manage site visits. Will help with resolving queries. * Provide support and coverage for Brighton research specimen lab including processing and shipping under the direction of lab supervisor. * Utilizes critical thinking skills to recognize and solve patient/participant problems including billing issues. * Communicates with nurses, IDS, physicians, NP's/PA's phlebotomists and other clinical and research staff to correct/prevent protocol errors. Expeditiously routes AE and SAE information between staff, PI, and oversight agencies as appropriate. * Serves as a resource and contact person for active protocols. * With guidance from Manager, liaison between clinical team and research team to develop processes, troubleshoot complications, and facilitate communication. * Integrates the workflow of many studies running simultaneously * Maintains current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintains knowledge of current ICH and CFR guidelines. * Provide coverage for other research staff. Assist in training other staff with guidance from Manager and Project Manager. * Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times. Required Qualifications* * Bachelor's Degree or higher preferably in health science or health related field. * At least one year of experience coordinating clinical research or at least one year experience working with patients in Michigan Medicine. * Excellent interpersonal, oral, and written communication skills with exceptional attention to detail. * Excellent computer skills including proficiency in Microsoft software applications. * Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines. * Willingness to be flexible in a dynamic working environment. * Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner. Desired Qualifications* * Clinical trials experience * Previous experience with EPIC, MiChart, Oncology research * SoCRA or ACRP certification Background Screening University of Michigan Health System 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. Application Deadline Job openings are posted for a minimum of seven calendar days. This job 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. U-M COVID-19 Vaccination Policy COVID-19 vaccinations are now required for all University of Michigan students, faculty and staff across all three campuses, including Michigan Medicine. This includes those working or learning remotely. More information on this policy is available on the Campus Blueprint

Keywords: University Of Michigan, Ann Arbor , Clinical Subjects Coordinator, Healthcare , Ann Arbor, Michigan

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