University Of Michigan
CRC - Project Manager underfill CRC Lead, CRC Senior
University Of Michigan, Ann Arbor, Michigan, us, 48113
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.
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* 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
DUTIES as a COORDINATING CENTER
Project Administration (Project Timelines, Project Meetings)
Regulatory (Central IRB, Trial Master File)
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.
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
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
Required Qualifications* 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 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.)
Desired Qualifications* CRC Project Manager
Project Management certification
9+ years of direct related experience
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
Work Schedule 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.
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 work modes .
Underfill Statement 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.
Additional Information
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
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO Statement The University of Michigan is an equal employment opportunity employer.
Job Opening ID 272396
Working Title #J-18808-Ljbffr
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* 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
DUTIES as a COORDINATING CENTER
Project Administration (Project Timelines, Project Meetings)
Regulatory (Central IRB, Trial Master File)
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.
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
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
Required Qualifications* 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 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.)
Desired Qualifications* CRC Project Manager
Project Management certification
9+ years of direct related experience
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
Work Schedule 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.
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 work modes .
Underfill Statement 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.
Additional Information
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
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO Statement The University of Michigan is an equal employment opportunity employer.
Job Opening ID 272396
Working Title #J-18808-Ljbffr