"CRC - Project Manager underfill CRC Lead, CRC Senior"

This clinical research coordinator (CRC) position may provide study coordination and/or project management for multiple clinical research studies of any complexity. 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.

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

DUTIES as a COORDINATING CENTER

• Project Administration (Project Timelines, Project Meetings)
• Regulatory (Central IRB, Trial Master File)
• Data Oversight (e.g. site monitoring, auditing, etc.)
• Demonstrates ability to create and manage the logistics for a new clinical research trial.
• Knowledge of the roles and responsibility of the various stakeholders in clinical research.
• Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency.

DUTIES as a PERFORMANCE SITE

• Clinical Coordinator Responsibilities
• Proficient in study implementation.
• Data Coordinator Responsibilities (e.g. data abstraction, data entry, etc.)
• Regulatory Coordinator Responsibilities
• Applies critical thinking and creative problem solving skills in the development of new processes, procedures, tools, and training to enhance clinical research activities.
• Demonstrates the ability to evaluate a monitoring plan against protocol and relates the plan to study team members.
• Manage workloads and resources/procurement.

ADMINISTRTIVE RESPONSIBILITIES

• Run staff meetings
• Mentorship of clinical research professionals
• Functional supervision
• Knowledge of the principles and practices of leadership, management, and mentorship, and how to apply them within the working environment

TRAINING

• All training requirements of the previous level.
• Specialty training or expertise is achieved at this level.
• Completes Michigan Medicine training for Managing Successfully and Leading Successfully.
• Attends and participates in all training assigned to this level.
• Other duties as assigned.

Supervision Received: This position reports directly to a Faculty Principal Investigator

Supervision Exercised: Provides Administrative supervision of 3 or more staff in titles on within the CRC Ladder or this position manages a portfolio of muti-site clinic research in which the University of Michigan is the lead center

CRC Project Manager:

• CRC Governance Committee review and approval
• Masters 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 or ACRP prior to applying.)
• Minimum 6 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

CRC Lead:

• CRC Governance Committee review and approval
• Bachelors 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 or ACRP prior to applying.)
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

CRC Senior:

• CRC Governance Committee review and approval
• Bachelors 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 or ACRP prior to applying.)
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

CRC Project Manager

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

CRC Lead:

• Masters degree in Health Science or an equivalent combination of related education and related experience is desirable
• 9+ years of direct related experience

CRC Senior:

• 9+ years of direct related experience

This position is hybrid, with at least 2-3 days/wk onsite work regularly in Ann Arbor, MI required. Work hours are Monday to Friday from 8:00 am to 5:00 p.m. There will be some travel to national meetings.

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

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.

• Supervision received: This position reports directly to a Faculty Principal Investigator.
• Continuation of research staff appointments is subject to performance that meets or exceeds the appointing unit and University criteria and the availability of continued funding.
• The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine