University of Michigan-Flint School of Management
Clinical Research Coord Inter TERM-LIMITED
University of Michigan-Flint School of Management, Ann Arbor, Michigan, us, 48113
Overview
Join to apply for the
Clinical Research Coord Inter TERM-LIMITED
role at
University of Michigan-Flint School of Management .
Responsibilities 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
Responsibilities
Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to:
Regulatory submissions, creation/maintenance of regulatory binders
Subject screening, consenting, enrollment, management of study records
Data collection, entry, sharing, storage, management, query resolution
Create and complete case report forms, source documentation, study documents and tools
Database/survey development in various electronic platforms (REDCap, Qualtrics)
Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeout
Assess studies for execution and troubleshoot potential implementation issues.
Provide cross-coverage on projects
Performs study procedures with accuracy
Demonstrates ability to triage complex study concerns appropriately
Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles
Resolves complicated queries
Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes
Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines
Provide other administrative support for study activity including management of subject reimbursement and payments
Participates in trainings specifically for maintaining certification as a Clinical Research Professional
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 or ACRP prior to applying.)
Minimum 3 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.)
Excellent organizational skills and attention to detail.
Superb interpersonal skills - comfortable speaking with healthcare providers, research sponsors, and patients.
Ability to communicate effectively and professionally in both verbal and written form.
Ability to work independently but also within a team.
Ability to prioritize multiple tasks and meet deadlines are a must.
Desired Qualifications
6+ years of direct related experience
Excellent communication skills
Ability to foresee needs of investigators/study teams and respond accordingly
Possess critical thinking skills
Ability to triage complex study concerns appropriately
Work Schedule This is a full-time regular position. Monday-Friday: 8am-4:30pm; On-site work required. Travel to satellite clinics may be required.
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.
Additional Information This is a term-limited appointment for 2 years, with an option to extend if funds are available.
At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.
Background Screening 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 Reporting 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 and Details Job Opening ID: 271713
Posting Begin/End Date: 12/12/2025 - 1/02/2026
Work Location: Ann Arbor Campus, Ann Arbor, MI
Modes of Work: Onsite
Full/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Exempt
Organizational Group: Medical School
Department: MM Orthopaedic Surgery
Career Interest: Research
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Higher Education
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Clinical Research Coord Inter TERM-LIMITED
role at
University of Michigan-Flint School of Management .
Responsibilities 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
Responsibilities
Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to:
Regulatory submissions, creation/maintenance of regulatory binders
Subject screening, consenting, enrollment, management of study records
Data collection, entry, sharing, storage, management, query resolution
Create and complete case report forms, source documentation, study documents and tools
Database/survey development in various electronic platforms (REDCap, Qualtrics)
Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeout
Assess studies for execution and troubleshoot potential implementation issues.
Provide cross-coverage on projects
Performs study procedures with accuracy
Demonstrates ability to triage complex study concerns appropriately
Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles
Resolves complicated queries
Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes
Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines
Provide other administrative support for study activity including management of subject reimbursement and payments
Participates in trainings specifically for maintaining certification as a Clinical Research Professional
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 or ACRP prior to applying.)
Minimum 3 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.)
Excellent organizational skills and attention to detail.
Superb interpersonal skills - comfortable speaking with healthcare providers, research sponsors, and patients.
Ability to communicate effectively and professionally in both verbal and written form.
Ability to work independently but also within a team.
Ability to prioritize multiple tasks and meet deadlines are a must.
Desired Qualifications
6+ years of direct related experience
Excellent communication skills
Ability to foresee needs of investigators/study teams and respond accordingly
Possess critical thinking skills
Ability to triage complex study concerns appropriately
Work Schedule This is a full-time regular position. Monday-Friday: 8am-4:30pm; On-site work required. Travel to satellite clinics may be required.
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.
Additional Information This is a term-limited appointment for 2 years, with an option to extend if funds are available.
At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.
Background Screening 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 Reporting 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 and Details Job Opening ID: 271713
Posting Begin/End Date: 12/12/2025 - 1/02/2026
Work Location: Ann Arbor Campus, Ann Arbor, MI
Modes of Work: Onsite
Full/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Exempt
Organizational Group: Medical School
Department: MM Orthopaedic Surgery
Career Interest: Research
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Higher Education
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr