What are the responsibilities and job description for the Clinical Research Intermediate/Associate position at Michigan Medicine?
How to Apply
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.
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.
Job Summary
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 CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children's Hospital. Our program is renowned for our expertise in cancers like leukemia, lymphoma, and solid tumors including neuroblastoma, sarcoma and brain tumors which affect children, adolescents, and young adults. We are members of national clinical trials organizations like COG, NANT, TACL and PNOC for pediatric and AYA cancer patients. 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. As a team member, we will invest in your education, training, career development and certification.
Responsibilities*
Characteristic Duties And Responsibilities
Experience as part of a team with all 8 competency domains is expected:
This position receives direct supervision and reports directly to a CRC-Lead, CRC-Senior, a unit Administrator, Director, or Faculty Principal Investigator. Functional supervision may be received from the Clinical Research Coordinator Senior in the team.
Supervision Exercised
None.
Required Qualifications*
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?
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.
Work Schedule
The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.
Underfill Statement
This position may be underfilled at the CRC-Associate or CRC-Technician titles based on selected candidates' qualifications.
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 anytime after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.
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.
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.
Job Summary
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 CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children's Hospital. Our program is renowned for our expertise in cancers like leukemia, lymphoma, and solid tumors including neuroblastoma, sarcoma and brain tumors which affect children, adolescents, and young adults. We are members of national clinical trials organizations like COG, NANT, TACL and PNOC for pediatric and AYA cancer patients. 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. As a team member, we will invest in your education, training, career development and certification.
Responsibilities*
Characteristic Duties And Responsibilities
Experience as part of a team with 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
- Assist study teams with all aspects of clinical trial coordination including identifying potential subjects, screening subjects, consenting (minimal risk) and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
- Coordinate and facilitate correct timing of study visits and procedures with patients and clinic staff
- Coordinate the collection and integrity of research specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)
- Monitor and report abnormal or unexpected findings
- Create source documents for accurate tracking, collection, and recording of experimental data
- Utilize critical thinking skills to recognize and solve patient/participant problems including billing issues
- Work collaboratively with nurses, research pharmacy, physicians, NPs/PAs, phlebotomists and other clinical, research and administrative staff to correct/prevent protocol errors
- Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate
- Possibly attend investigator and scientific meetings
- Serve as a resource and contact person for active protocols
- Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
- Integrate the workflow of many studies running simultaneously
- Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintain knowledge of current ICH and CFR guidelines
- Assist in the completion of regulatory duties including new study activation and processing of amendments and continuing reviews
- Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
- In coordination with the CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
- Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues
This position receives direct supervision and reports directly to a CRC-Lead, CRC-Senior, a unit Administrator, Director, or Faculty Principal Investigator. Functional supervision may be received from the Clinical Research Coordinator Senior in the team.
Supervision Exercised
None.
Required Qualifications*
- Bachelor's Degree or higher preferably in health science or health related field or an equivalent combination of related education and experience.
- At least two years of experience coordinating Clinical Trials.
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
- Excellent computer skills including proficiency in Microsoft software applications.
- Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.
- Willingness to be flexible in a dynamic working environment.
- Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
- Good attendance record
- 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 and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
- Minimum 3 years of directly related experience in clinical research and clinical trials.
- 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 and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
- Minimum 2 years of directly related experience in clinical research and clinical trials.
- Associate degree or an equivalent combination of related education and experience.
- Minimum 1 year of directly related experience in clinical research and clinical trials.
- 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
- 6 years of direct related experience
- Masters Degree
- Reasonable understanding of clinical research
- Understanding of medical terminology related to oncology
- Some IRB/regulatory experience
- Previous experience with Epic, MiChart, eResearch, OnCore, RedCap
- Certification or planned certification through ACRP or SOCRA
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
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.
Work Schedule
The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.
Underfill Statement
This position may be underfilled at the CRC-Associate or CRC-Technician titles based on selected candidates' qualifications.
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 anytime after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.