Northwestern University
Clinical Research Coordinator
Northwestern University, Chicago, Illinois, United States, 60290
Clinical Research Coordinator
– Northwestern University
Department:
MED-Neurology
Salary/Grade:
EXS/5
Target hiring range for this position will be between $51,346 and $64,470 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.
Job Summary Manages daily operations of a biomedical and/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors, and other external project stakeholders. Monitors study performance, analyzes and reviews results, and supervises the development and implementation of new protocols. Assigns work and supervises study staff and reviews technical operations ensuring that all processes, protocols, and procedures are quality‑controlled and functioning up to standards. May co‑author scientific papers for presentation and publication and coordinate writing, submission, and administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy, and procedures developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). The supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objectives, deadlines, and overall compliance with policy and procedures. Employees complete some activities without direction, informing the supervisor only of potentially controversial matters and/or far‑reaching implications.
Responsibilities
Technical
– Lead execution and control of a biomedical and/or social science project or research study. Manage and ensure completion of study activities per protocol. Collaborate with nursing staff and Principal Investigator (PI) to ascertain pretreatment and eligibility requirements; interview participants and obtain social and medical histories; based on results determine and register participants with appropriate sponsors; complete informed consent; determine and organize patient’s treatment and test schedules. Manage conduct of experimental tests and procedures. Closely monitor and document patient’s adverse events; partner with nursing staff in modifying dosages, tests, and treatment schedule.
Data
– Manage project data including processing, accuracy, analysis, and evaluation of data to ensure that results meet project information and deliverable objectives. Partner with internal and external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports. Provide consultation to internal and external project staff on appropriate data management, methodological issues, and analysis of data.
Administration
– Manage project, collaborating with and partnering with all internal and external staff including sponsoring agencies, organizations, and other research and educational institutions to ensure project objectives and timelines are attained. Advise project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project. Manage day‑to‑day project operational and business functions; implement existing policy and ensure the effective, compliant, and efficient completion of daily administrative operations. Ensure appropriate and timely compliance with associated local, state, and federal regulatory guidelines, requirements, and laws.
Miscellaneous
– Perform other duties as assigned.
Minimum Qualifications
Successful completion of a full 4‑year course of study at an accredited college or university leading to a bachelor’s or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years’ research study or other relevant experience.
Successful completion of a full course of study at an accredited college or university leading to a master’s or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year of research study or other relevant experience.
Must complete NU’s IRB CITI training before interacting with any participants and must re‑certify every 3 years.
Benefits At Northwestern, we are proud to provide meaningful, competitive, high‑quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.
Work‑Life And Wellness Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.
Professional Growth & Development Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern’s non‑discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.
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– Northwestern University
Department:
MED-Neurology
Salary/Grade:
EXS/5
Target hiring range for this position will be between $51,346 and $64,470 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.
Job Summary Manages daily operations of a biomedical and/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors, and other external project stakeholders. Monitors study performance, analyzes and reviews results, and supervises the development and implementation of new protocols. Assigns work and supervises study staff and reviews technical operations ensuring that all processes, protocols, and procedures are quality‑controlled and functioning up to standards. May co‑author scientific papers for presentation and publication and coordinate writing, submission, and administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy, and procedures developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). The supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objectives, deadlines, and overall compliance with policy and procedures. Employees complete some activities without direction, informing the supervisor only of potentially controversial matters and/or far‑reaching implications.
Responsibilities
Technical
– Lead execution and control of a biomedical and/or social science project or research study. Manage and ensure completion of study activities per protocol. Collaborate with nursing staff and Principal Investigator (PI) to ascertain pretreatment and eligibility requirements; interview participants and obtain social and medical histories; based on results determine and register participants with appropriate sponsors; complete informed consent; determine and organize patient’s treatment and test schedules. Manage conduct of experimental tests and procedures. Closely monitor and document patient’s adverse events; partner with nursing staff in modifying dosages, tests, and treatment schedule.
Data
– Manage project data including processing, accuracy, analysis, and evaluation of data to ensure that results meet project information and deliverable objectives. Partner with internal and external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports. Provide consultation to internal and external project staff on appropriate data management, methodological issues, and analysis of data.
Administration
– Manage project, collaborating with and partnering with all internal and external staff including sponsoring agencies, organizations, and other research and educational institutions to ensure project objectives and timelines are attained. Advise project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project. Manage day‑to‑day project operational and business functions; implement existing policy and ensure the effective, compliant, and efficient completion of daily administrative operations. Ensure appropriate and timely compliance with associated local, state, and federal regulatory guidelines, requirements, and laws.
Miscellaneous
– Perform other duties as assigned.
Minimum Qualifications
Successful completion of a full 4‑year course of study at an accredited college or university leading to a bachelor’s or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years’ research study or other relevant experience.
Successful completion of a full course of study at an accredited college or university leading to a master’s or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year of research study or other relevant experience.
Must complete NU’s IRB CITI training before interacting with any participants and must re‑certify every 3 years.
Benefits At Northwestern, we are proud to provide meaningful, competitive, high‑quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.
Work‑Life And Wellness Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.
Professional Growth & Development Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern’s non‑discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.
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