Clinical research h1.location_city

Summary

The department of Radiology is seeking an experienced clinical research professional to support and manage clinical research activity. This clinical research coordinator (CRC) position will provide support, oversight, and/or project management for all clinical research studies in the department of Radiology. This position will also oversee the intake and review process for clinical trials requesting the use of Radiology's resources for clinical research.

Coordinator experience and mastery of all job duties on the Michigan Medicine CRC Career Ladder is required. This position has achieved mastery in all aspects of clinical research management. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs including project staff. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree. This position applies skills and knowledge to leading and directing others. It is important that candidates have experience in supervision and a vision for mentorship and coordinator training.

This position may be underfilled at the CRC-Lead or CRC-Senior titles based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Responsibilities*

Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) 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

Department specific duties include:

• Establishing standards for clinical research studies based on ethics, regulatory compliance, and best practices. Education/training of personnel and investigators on expectations.Internal reviews of trials for compliance.
• Maintaining and operating a process to review all Michigan Medicine trials requiring Radiology resources. Guiding a dedicated staff memberMaintaining a database of trialsReviewing/approving proposalsCommunication with the clinical trials support units and/or study teamsFinancial management and invoicing trials for this review service
• Manage effort for team of coordinatorsBudgeting effort for potential trialsEffort allocation for trials (and associated financial details)
• Coordination across Michigan Medicine units for trial supportPoint person for communication with clinical trials support unitsTrial budgetingInvestigator training/onboardingSupport for trials involving for investigational devices and drugs.
• Other duties as assigned.

Required Qualifications*

Mandatory for all titles:

• CRC Governance Committee review and approval.
• Certification is required through Association of Clinical Research Professionals (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

Clinical Research Project Manager:

• Master's Degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 6 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA'sfor qualifying experience prior to applying.)

Clinical Research Coordinator Lead or Senior (Underfill):

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Desired Qualifications*

Clinical Research Project Manager:

• Project Management certification
• Supervisory experience
• 9+ years of direct related experience

Clinical Research Coordinator Lead (Underfill):

• Master's Degree in Health Science or an equivalent combination of related education and related experience is desirable.
• 9+ years of direct related experience

Clinical Research Coordinator Senior (Underfill):

• 9+ years of direct related experience

Work Schedule

Weekdays (Monday-Friday), 9am-5pm

Work Locations

Victor Vaughn Building

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the