Clinical Research Coordinator Senior underfill Clinical Research Coordinator Intermediate

Clinical Research Coordinator Senior underfill Clinical Research Coordinator Intermediate

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate and/or CRC-Senior position on the Michigan Medicine CRC Career Ladder is required. This position demonstrates the ability to lead study team members in the implementation of study related activities. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others.

This position 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, develop, evaluate, lead, guide, mentor, and support.

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.

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

Characteristic

Duties and Responsibilities:

Contribute to the development of process/tools and lead others in 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

Clinical Coordinator Responsibilities

• Develops tools, processes, and training to enhance the administration and execution of clinical trials.
• Designs processes and tools to assess study execution and leads team on accurate implementation of protocol.
• Develops processes, tools, and training to support the non-GCP-related activities associated with study execution.
• Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures.
• Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently.
• Performs at the highest level of data management and results reporting.

Regulatory Coordinator Responsibilities

• Develop processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
• Monitors site compliance with subject safety reporting, accelerate issues, and develops tools, processes, and training to enhance subject safety during the conduct of a clinical study

Administrative Responsibilities

• Leads a team of coordinators in support of clinical research.
• Functional supervision of clinical research staff and temporary staff.
• Demonstrates professionalism and applies well-developed leadership practices in all aspects of the role of the CRC.
• Oversees study conducted by staff and guides quality assurance efforts.
• Responsible for recommendations on workload assessments and distribution.
• Develops processes, tools,…