Clinical Research Coordinator Intermediate

Clinical Research Coordinator Intermediate Job Summary

This Clinical Research Coordinator Intermediate (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-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.

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.

Characteristic

Duties and Responsibilities:

Expert level 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

Assist study team with aspects of clinical research coordination including identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.

Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).

Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).

Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.

In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures.

Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits.

Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.

Prepare and organize space for study related materials and equipment.

The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.

Staff members are expected to work independently and regularly exercise good judgment in setting…