University of Michigan
Program Manager for StrokeNet
University of Michigan, Ann Arbor, Michigan, us, 48113
Program Manager for StrokeNet
Apply Now
Job Summary
Emergency Medicine is seeking an experienced, motivated, organized, and positive individual to serve as the program manager for Michigan StrokeNet. Primary responsibilities include providing leadership and support for the conduct of stroke-related clinical trials at the University of Michigan and to guide and facilitate clinical trial implementation and operation at affiliated Michigan StrokeNet sites. Trials may include stroke prevention, treatment, recovery interventions and biomarker studies.
The program manager will act as a liaison to the sponsor, regulatory agencies, research subjects, IRB, investigators, national coordinating center (University of Cincinnati) and the other clinical enrollment sites. In addition, they will provide both research administration and oversight of study coordination for multiple clinical research studies.
Background: The University of Michigan is one of 27 Regional Coordinating Centers (RCCs) for the National Institutes of Health (NIH) StrokeNet clinical trials network. The network of RCCs spans the US, including some 500 hospitals and serves as the infrastructure and pipeline for new potential treatments for patients with stroke and those at risk for stroke. The network also collaborates with sites in other countries including Canada, Germany, United Kingdom, Spain, and Japan. In addition, StrokeNet provides an educational platform for stroke physicians, clinical trial coordinators and stroke researchers.
Michigan StrokeNet (RCC-17) includes hospitals in Michigan, Ohio, Kentucky, and Pennsylvania. There are currently ten active trials in Michigan StrokeNet hospitals.
Responsibilities*
Provide leadership and support for the conduct of stroke-related clinical trials at the University of Michigan and at all sites in Michigan StrokeNet (RCC-17)
Guide and facilitate clinical trial implementation locally and at RCC-17 network sites
Continue to develop the infrastructure for the RCC-17 trial network.
Oversee the daily coordination of the Michigan RCC locally and at all clinical sites to ensure compliance with local and federal requirements for initiation and ongoing performance of clinical trials.
Assist the principal investigators (PIs) in trial start-up, protocol training for clinical trial study personnel, maintenance of regulatory documents, monitoring the quality of data and GCP compliance at each site, and monitoring recruitment and retention, and coordination with the other sites within the regional network.
Assist the PIs in devising corrective action plans as needed.
Serve on the StrokeNet managers national leadership team.
Implementation and management of all phases of trial protocols including screening, enrollment, outcome assessments as needed.
Travel to one to two national StrokeNet meetings annually (AHA International Stroke Meeting (Spring) and NIH Annual network meeting (Fall)
The program manager will act as a liaison to the sponsor, regulatory agencies, research subjects, IRB, investigators, and the other clinical enrollment sites.
The incumbent will assist with development of grant applications, pre-award and post-award grant management, and monitoring of budget and expenditures.
Required Qualifications*
Prior management of or participation in clinical trials.
Ability to work independently as well as with the clinical trial team.
Bachelor's degree or higher in Health Science or an equivalent combination of related education and experience.
Experience with institutional and single/central Institutional Review Boards
Professional demeanor and excellent interpersonal and communication skills.
Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
Outstanding organizational skills with meticulous attention to detail.
Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
Strong problem-solving skills.
Ability to adhere to established timelines to accomplish tasks.
Demonstrated ability to learn and use new skills quickly and effectively.
Able to maintain data confidentiality and participant/subject/patient privacy.
Excellent attendance record and strong work ethic.
Desired Qualifications*
RN or a master's degree in a health-related field
Experience with clinical trial project management
Prior grant management and grant preparation experience
Experience managing research personnel
Experience developing and managing grant budgets
Experience with federally sponsored and/or industry-sponsored clinical studies.
Experience using e-Research Regulatory Management system, OnCore Clinical Trial Management System, and MiChart.
Experience with Electronic Data Entry/Capture (EDC).
A working knowledge of medical terminology and assessment of laboratory values.
ACRP or SOCRA certified.
ICH-GCP certified through CITI, HIPAA, and PEERRS training.
Experience in database development and management (including developing surveys) using REDCap.
Understanding of OHRP and FDA regulations.
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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
Job Detail
Job Opening ID
256407
Working Title
Program Manager for StrokeNet
Job Title
Program Manager
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Hybrid
Full/Part Time
Part-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Emergency Medicine Research
Posting Begin/End Date
11/01/2024 - 11/08/2024
Career Interest
Administration
Apply Now
Apply Now
Job Summary
Emergency Medicine is seeking an experienced, motivated, organized, and positive individual to serve as the program manager for Michigan StrokeNet. Primary responsibilities include providing leadership and support for the conduct of stroke-related clinical trials at the University of Michigan and to guide and facilitate clinical trial implementation and operation at affiliated Michigan StrokeNet sites. Trials may include stroke prevention, treatment, recovery interventions and biomarker studies.
The program manager will act as a liaison to the sponsor, regulatory agencies, research subjects, IRB, investigators, national coordinating center (University of Cincinnati) and the other clinical enrollment sites. In addition, they will provide both research administration and oversight of study coordination for multiple clinical research studies.
Background: The University of Michigan is one of 27 Regional Coordinating Centers (RCCs) for the National Institutes of Health (NIH) StrokeNet clinical trials network. The network of RCCs spans the US, including some 500 hospitals and serves as the infrastructure and pipeline for new potential treatments for patients with stroke and those at risk for stroke. The network also collaborates with sites in other countries including Canada, Germany, United Kingdom, Spain, and Japan. In addition, StrokeNet provides an educational platform for stroke physicians, clinical trial coordinators and stroke researchers.
Michigan StrokeNet (RCC-17) includes hospitals in Michigan, Ohio, Kentucky, and Pennsylvania. There are currently ten active trials in Michigan StrokeNet hospitals.
Responsibilities*
Provide leadership and support for the conduct of stroke-related clinical trials at the University of Michigan and at all sites in Michigan StrokeNet (RCC-17)
Guide and facilitate clinical trial implementation locally and at RCC-17 network sites
Continue to develop the infrastructure for the RCC-17 trial network.
Oversee the daily coordination of the Michigan RCC locally and at all clinical sites to ensure compliance with local and federal requirements for initiation and ongoing performance of clinical trials.
Assist the principal investigators (PIs) in trial start-up, protocol training for clinical trial study personnel, maintenance of regulatory documents, monitoring the quality of data and GCP compliance at each site, and monitoring recruitment and retention, and coordination with the other sites within the regional network.
Assist the PIs in devising corrective action plans as needed.
Serve on the StrokeNet managers national leadership team.
Implementation and management of all phases of trial protocols including screening, enrollment, outcome assessments as needed.
Travel to one to two national StrokeNet meetings annually (AHA International Stroke Meeting (Spring) and NIH Annual network meeting (Fall)
The program manager will act as a liaison to the sponsor, regulatory agencies, research subjects, IRB, investigators, and the other clinical enrollment sites.
The incumbent will assist with development of grant applications, pre-award and post-award grant management, and monitoring of budget and expenditures.
Required Qualifications*
Prior management of or participation in clinical trials.
Ability to work independently as well as with the clinical trial team.
Bachelor's degree or higher in Health Science or an equivalent combination of related education and experience.
Experience with institutional and single/central Institutional Review Boards
Professional demeanor and excellent interpersonal and communication skills.
Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
Outstanding organizational skills with meticulous attention to detail.
Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
Strong problem-solving skills.
Ability to adhere to established timelines to accomplish tasks.
Demonstrated ability to learn and use new skills quickly and effectively.
Able to maintain data confidentiality and participant/subject/patient privacy.
Excellent attendance record and strong work ethic.
Desired Qualifications*
RN or a master's degree in a health-related field
Experience with clinical trial project management
Prior grant management and grant preparation experience
Experience managing research personnel
Experience developing and managing grant budgets
Experience with federally sponsored and/or industry-sponsored clinical studies.
Experience using e-Research Regulatory Management system, OnCore Clinical Trial Management System, and MiChart.
Experience with Electronic Data Entry/Capture (EDC).
A working knowledge of medical terminology and assessment of laboratory values.
ACRP or SOCRA certified.
ICH-GCP certified through CITI, HIPAA, and PEERRS training.
Experience in database development and management (including developing surveys) using REDCap.
Understanding of OHRP and FDA regulations.
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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
Job Detail
Job Opening ID
256407
Working Title
Program Manager for StrokeNet
Job Title
Program Manager
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Hybrid
Full/Part Time
Part-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Emergency Medicine Research
Posting Begin/End Date
11/01/2024 - 11/08/2024
Career Interest
Administration
Apply Now