University Of Michigan
Clinical Research Coord Assoc/Technician/Assistant
University Of Michigan, Ann Arbor, Michigan, us, 48113
Clinical Research Coord Assoc/Technician/Assistant
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Job Summary This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Rogel Cancer Center providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice‑changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers™. Help discover them.
This clinical Research Coordinator (CRC) 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 the CRC‑Technician position on the Michigan Medicine CRC Career Ladder 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 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.
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* Characteristic Duties and Responsibilities:
Independent 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
Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Clinic. Examples of duties a successful candidate in this role will perform:
Clinical Research Coordinator - Associate
Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
Demonstrates the ability to anticipate and mitigate the potential for protocol non‑compliance.
Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
Demonstrates accurate implementation of protocol procedures.
Explains and performs non‑GCP‑related study management activities.
Performs study procedures with minimal supervision.
Triages simple subject issues appropriately.
Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
This position reports directly to a CRC‑Lead, CRC‑Project Manager, or a unit Administrator, Director.
Clinical Research Coordinator - Technician
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.
Performs moderately complex study procedures with accuracy.
Triages simple subject concerns appropriately.
Assesses studies for execution and troubleshoots potential implementation issues.
Completes simple to moderately complex data collection during study visits.
May work with CTSUs to reconcile financial accounts for study participants.
Assists with local quality control efforts.
Clinical Research Coordinator - Assistant
This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long‑term follow‑up, and other non‑interventional studies.
Demonstrates the ability to screen participants for study eligibility.
Performs simple study procedures with accuracy.
Understands protocol structure and how to interpret study requirements to ensure study compliance.
Understands proper documentation techniques, as outlined in the ICH‑GCP guidelines.
May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team.
Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC.
May mark visits as planned/occurred in OnCore.
May provide lab results, not interpretation, to participants.
May assist research coordinator in conduct of SIV; attends SIV.
May assist in and attend monitor visits and/or audits.
Required Qualifications* Clinical Research Coordinator - Associate
Bachelor's Degree in Health Science or equivalent in combined education and clinical research 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 etc.
within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP )
Clinical Research Coordinator - Technician
Associate degree in Health Science or an equivalent combination of related education and experience.
An advanced degree in a health‑related areas 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.
Clinical Research Coordinator - Assistant
High School Diploma or GED
Desired Qualifications* Clinical Research Coordinator - Associate
4+ years of direct related experience
Clinical Research Coordinator - Technician
Bachelor's Degree; Health Science field preferred or related certification
Understanding of medical terminology
Experience in a large, complex, healthcare setting
Ability to effectively communicate with staff and faculty of all levels
Knowledge of University policies and procedures
Clinical Research Coordinator - Assistant
Bachelor's Degree, Associate Degree, some college; Health Science field preferred or related certification
Understanding of medical terminology
Experience in a large, complex, healthcare setting
Ability to effectively communicate with staff and faculty of all levels
Knowledge of University policies and procedures
Work Schedule Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.
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 the CRC‑Technician or CRC‑Assistant titles based on selected candidates' qualifications.
Additional Information Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
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.
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Job Summary This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Rogel Cancer Center providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice‑changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers™. Help discover them.
This clinical Research Coordinator (CRC) 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 the CRC‑Technician position on the Michigan Medicine CRC Career Ladder 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 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.
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* Characteristic Duties and Responsibilities:
Independent 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
Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Clinic. Examples of duties a successful candidate in this role will perform:
Clinical Research Coordinator - Associate
Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
Demonstrates the ability to anticipate and mitigate the potential for protocol non‑compliance.
Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
Demonstrates accurate implementation of protocol procedures.
Explains and performs non‑GCP‑related study management activities.
Performs study procedures with minimal supervision.
Triages simple subject issues appropriately.
Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
This position reports directly to a CRC‑Lead, CRC‑Project Manager, or a unit Administrator, Director.
Clinical Research Coordinator - Technician
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.
Performs moderately complex study procedures with accuracy.
Triages simple subject concerns appropriately.
Assesses studies for execution and troubleshoots potential implementation issues.
Completes simple to moderately complex data collection during study visits.
May work with CTSUs to reconcile financial accounts for study participants.
Assists with local quality control efforts.
Clinical Research Coordinator - Assistant
This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long‑term follow‑up, and other non‑interventional studies.
Demonstrates the ability to screen participants for study eligibility.
Performs simple study procedures with accuracy.
Understands protocol structure and how to interpret study requirements to ensure study compliance.
Understands proper documentation techniques, as outlined in the ICH‑GCP guidelines.
May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team.
Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC.
May mark visits as planned/occurred in OnCore.
May provide lab results, not interpretation, to participants.
May assist research coordinator in conduct of SIV; attends SIV.
May assist in and attend monitor visits and/or audits.
Required Qualifications* Clinical Research Coordinator - Associate
Bachelor's Degree in Health Science or equivalent in combined education and clinical research 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 etc.
within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP )
Clinical Research Coordinator - Technician
Associate degree in Health Science or an equivalent combination of related education and experience.
An advanced degree in a health‑related areas 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.
Clinical Research Coordinator - Assistant
High School Diploma or GED
Desired Qualifications* Clinical Research Coordinator - Associate
4+ years of direct related experience
Clinical Research Coordinator - Technician
Bachelor's Degree; Health Science field preferred or related certification
Understanding of medical terminology
Experience in a large, complex, healthcare setting
Ability to effectively communicate with staff and faculty of all levels
Knowledge of University policies and procedures
Clinical Research Coordinator - Assistant
Bachelor's Degree, Associate Degree, some college; Health Science field preferred or related certification
Understanding of medical terminology
Experience in a large, complex, healthcare setting
Ability to effectively communicate with staff and faculty of all levels
Knowledge of University policies and procedures
Work Schedule Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.
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 the CRC‑Technician or CRC‑Assistant titles based on selected candidates' qualifications.
Additional Information Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
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.
#J-18808-Ljbffr