Clinical Research Coord Inter

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.

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 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 TM. Help discover them.

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.

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Minimum 3 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.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a…