"Clinical Research Coordinator Intermediate"

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.

This position will serve as a Clinical Research Coordinator Intermediate 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 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-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

Characteristic Duties and Responsibilities:

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. 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 Regulatory. 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.
• 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.
• Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits.
• Demonstrates ability to resolve complex queries.
• Demonstrates ability to create CRFs, study documents, and tools.

This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator.

This position could provide functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

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 orACRP)
• 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.
• 6+ years of direct related experience.

Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.