Michigan Medicine
Job Summary
This position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from previous job description is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
Characteristic Duties and Responsibilities
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
Handle clinical patient enrollment
Administer patient reported outcome surveys
Transfer biospecimens from clinic/OR to the lab
Maintain human subjects database
Required Qualifications – CRC Associate
Bachelor's degree in Health Science or an equivalent combination of related education and experience.
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 within six months of date of hire.
Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.
Training requirements:
PEERRS, HIPAA, CITI GCP.
eRPM Regulatory training.
Attends and participates in all training assigned to this level.
Required Qualifications – CRC Technician
Associate degree in Health Science or an equivalent combination of related education and experience.
ONE of the following:
Minimum 1 year of directly related experience in clinical research and clinical trials is necessary.
An advanced degree in a health-related area such as Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
Training Requirements:
PEERRS, HIPAA, CITI GCP.
Gain appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
Willing to learn and use available technology and systems to accomplish job requirements.
Understands the disease process per program.
Attends and participates in all training classes assigned to this level.
Assists with training activities of staff and others.
Desired Qualifications
Bachelor's degree in Health Science.
Experience with REDCap.
Experience enrolling patients and providing informed consent.
Experience administering patient surveys.
Experience with clinical studies (not necessarily clinical trials).
An understanding of medical terminology, experience in large complex health care setting.
Ability to effectively communicate with staff, patients.
Knowledge of university policies and procedures is desirable.
An understanding of medical terminology.
Work Schedule This position will primarily support work Monday-Friday 8:00am-4:30pm.
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.
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 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 any time after the minimum posting period has ended.
U‑M EEO Statement The University of Michigan is an equal employment opportunity employer.
Employment Details Seniority level: Entry level Employment type: Full‑time Job function: Research, Analyst, and Information Technology Industries: Hospitals and Health Care
Referrals Referrals increase your chances of interviewing at Michigan Medicine by 2x.
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Characteristic Duties and Responsibilities
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
Handle clinical patient enrollment
Administer patient reported outcome surveys
Transfer biospecimens from clinic/OR to the lab
Maintain human subjects database
Required Qualifications – CRC Associate
Bachelor's degree in Health Science or an equivalent combination of related education and experience.
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 within six months of date of hire.
Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.
Training requirements:
PEERRS, HIPAA, CITI GCP.
eRPM Regulatory training.
Attends and participates in all training assigned to this level.
Required Qualifications – CRC Technician
Associate degree in Health Science or an equivalent combination of related education and experience.
ONE of the following:
Minimum 1 year of directly related experience in clinical research and clinical trials is necessary.
An advanced degree in a health-related area such as Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
Training Requirements:
PEERRS, HIPAA, CITI GCP.
Gain appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
Willing to learn and use available technology and systems to accomplish job requirements.
Understands the disease process per program.
Attends and participates in all training classes assigned to this level.
Assists with training activities of staff and others.
Desired Qualifications
Bachelor's degree in Health Science.
Experience with REDCap.
Experience enrolling patients and providing informed consent.
Experience administering patient surveys.
Experience with clinical studies (not necessarily clinical trials).
An understanding of medical terminology, experience in large complex health care setting.
Ability to effectively communicate with staff, patients.
Knowledge of university policies and procedures is desirable.
An understanding of medical terminology.
Work Schedule This position will primarily support work Monday-Friday 8:00am-4:30pm.
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.
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 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 any time after the minimum posting period has ended.
U‑M EEO Statement The University of Michigan is an equal employment opportunity employer.
Employment Details Seniority level: Entry level Employment type: Full‑time Job function: Research, Analyst, and Information Technology Industries: Hospitals and Health Care
Referrals Referrals increase your chances of interviewing at Michigan Medicine by 2x.
#J-18808-Ljbffr