Clinical Research Coord Inter

Summary

The Division of Gastroenterology and Hepatology at the University of Michigan is recruiting a full-time Clinical Research Coordinator to join its thriving team. One specific focus for this position will be to help manage projects related to the complications of cirrhosis with a focus on liver cancer development. The primary responsibility for this position will be managing a portfolio of studies around liver cancer screening and development. The responsibilities include consenting patients, interacting with sponsors, and other sites, and maintaining regulatory approval. If desired candidates may also develop an academic resume in the position, with opportunities for writing and publication. All studies are industry or federally funded.

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-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.

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.

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*

• Verifying patient eligibility for studies via medical chart reviews

• Recruiting patients for study participation and obtaining informed consent

• Coordinating study visits with patients and hepatology providers

• Performing data collection (face-to-face surveys, chart reviews) and data quality assurance checks

• Performing sample collection and initial processing

• Monitoring study inventory and purchasing supplies

• Maintaining study data using REDCap (Research Electronic Data Capture) or other programs.

• Preparing study reports, annual reviews, and Institutional Review Board documentation

• Monitoring and evaluating protocol compliance

• Assisting with data analysis and preparation of manuscripts and conference presentations

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

Supervision Received: This position reports directly to a faculty PI

Supervision Exercised: 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 is necessary.

• 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