Northwestern University
Clinical Research Project Manager
Northwestern University, Chicago, Illinois, United States, 60290
Overview
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration. Department:
MED-Physical Med & Rehab
Salary/Grade:
EXS/7
Location:
Chicago, Illinois
Target hiring range for this position will be between $65,000-$77,000 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 all activities associated with biomedical and/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; and/or multi-million dollar budgets. Ensures completion of contract requirements and client specifications. Oversees day-to-day operations including identifying and securing needed resources; creating, implementing, monitoring, and updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones and/or goals are attained; monitoring and reporting progress as appropriate; and resolving or escalating issues in a timely manner. May co-author scientific papers for presentation and publication and coordinates 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 procedure developed by the NU Institutional Review Board (IRB), FDA CFR, and ICH.
Responsibilities:
Technical
Provides complex scientific and technical leadership in determining research priorities and the plan, design and execution of research projects ensuring that programs of investigation meet specified objectives.
Plans, develops and implements new processes and protocols to support research studies and maximize/extend study capabilities.
Oversees completion of study activities per protocol. Collaborates with nursing staff and PI to ascertain pretreatment and eligibility requirements; interviews participants and obtains social and medical histories; based on results determines and registers participants with appropriate sponsors; completes informed consent; determines and organizes patient’s treatment and test schedules.
Ensures study protocols comply with applicable rules and regulations; reviews study progress and recommends revisions or changes as necessary to meet sponsor needs.
Manages conduct of experimental tests and procedures; closely monitors and documents patient adverse events; partners with nursing staff in modifying dosages, tests and treatment schedules.
Reviews scientific literature and evaluates and recommends applicable techniques and procedures.
Administrative
Analyzes, evaluates and interprets data to determine relevance to research.
Assists PI in developing statistical methods and models to analyze and report data based on study requirements.
Prepares results and may co-author scientific papers for presentation and publication; disseminates information via seminars and lectures.
Creates data for use in grant submission and develops new proposals for research including obtaining financial support.
Acts as liaison between sponsoring agencies, collaborating organizations and/or other research and/or educational institutions.
Ensures that all study documents associated with current regulatory guidelines and protocols are completed in a timely manner.
Data
Manages project data including processing, accuracy, analysis and evaluation of data ensuring results meet project objectives.
Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports.
Provides consultation to internal/external project staff on data management and analysis issues.
Finance
May create and/or manage research study budgets, including expenditures based on budget.
Monitors accounts; negotiates prices and specifications with vendors.
Purchases supplies, materials, equipment and services; ensures appropriate allocation and compliance.
Invoices study sponsors for study tests/procedures and coordinates budget negotiations with industry sponsors.
Supervision
Trains, directs, assigns duties to and may supervise lab EEs, students, residents and/or fellows.
Acts as a mentor in regard to the education of junior coordinators.
Miscellaneous Performs other duties as assigned.
Minimum Qualifications
Successful completion of a full 4-year course of study leading to a bachelor’s or higher degree in social or health science or related; OR an appropriate combination of education and experience and 5 years’ research study or other relevant experience.
Successful completion of a full course of study 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 3 years’ research study or other relevant experience.
Supervisory or project management experience required.
Must complete NU's IRB CITI training before interacting with any participants and re-certify every 3 years.
Minimum Competencies
Experience with financial systems and reports, particularly regarding clinical trials and interactions with sponsors
Knowledge of clinical trial operations and management, including recruitment and/or coordination
Minimum of 4 years’ experience in clinical research fields
Knowledge of GCP
Preferred Qualifications
BA/BS degree required with Master’s degree preferred
Preferred Competencies
Knowledge of REDCap, NU systems
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 childcare and senior/adult care. Visit 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 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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Be one of the first applicants, read the complete overview of the role below, then send your application for consideration. Department:
MED-Physical Med & Rehab
Salary/Grade:
EXS/7
Location:
Chicago, Illinois
Target hiring range for this position will be between $65,000-$77,000 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 all activities associated with biomedical and/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; and/or multi-million dollar budgets. Ensures completion of contract requirements and client specifications. Oversees day-to-day operations including identifying and securing needed resources; creating, implementing, monitoring, and updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones and/or goals are attained; monitoring and reporting progress as appropriate; and resolving or escalating issues in a timely manner. May co-author scientific papers for presentation and publication and coordinates 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 procedure developed by the NU Institutional Review Board (IRB), FDA CFR, and ICH.
Responsibilities:
Technical
Provides complex scientific and technical leadership in determining research priorities and the plan, design and execution of research projects ensuring that programs of investigation meet specified objectives.
Plans, develops and implements new processes and protocols to support research studies and maximize/extend study capabilities.
Oversees completion of study activities per protocol. Collaborates with nursing staff and PI to ascertain pretreatment and eligibility requirements; interviews participants and obtains social and medical histories; based on results determines and registers participants with appropriate sponsors; completes informed consent; determines and organizes patient’s treatment and test schedules.
Ensures study protocols comply with applicable rules and regulations; reviews study progress and recommends revisions or changes as necessary to meet sponsor needs.
Manages conduct of experimental tests and procedures; closely monitors and documents patient adverse events; partners with nursing staff in modifying dosages, tests and treatment schedules.
Reviews scientific literature and evaluates and recommends applicable techniques and procedures.
Administrative
Analyzes, evaluates and interprets data to determine relevance to research.
Assists PI in developing statistical methods and models to analyze and report data based on study requirements.
Prepares results and may co-author scientific papers for presentation and publication; disseminates information via seminars and lectures.
Creates data for use in grant submission and develops new proposals for research including obtaining financial support.
Acts as liaison between sponsoring agencies, collaborating organizations and/or other research and/or educational institutions.
Ensures that all study documents associated with current regulatory guidelines and protocols are completed in a timely manner.
Data
Manages project data including processing, accuracy, analysis and evaluation of data ensuring results meet project objectives.
Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports.
Provides consultation to internal/external project staff on data management and analysis issues.
Finance
May create and/or manage research study budgets, including expenditures based on budget.
Monitors accounts; negotiates prices and specifications with vendors.
Purchases supplies, materials, equipment and services; ensures appropriate allocation and compliance.
Invoices study sponsors for study tests/procedures and coordinates budget negotiations with industry sponsors.
Supervision
Trains, directs, assigns duties to and may supervise lab EEs, students, residents and/or fellows.
Acts as a mentor in regard to the education of junior coordinators.
Miscellaneous Performs other duties as assigned.
Minimum Qualifications
Successful completion of a full 4-year course of study leading to a bachelor’s or higher degree in social or health science or related; OR an appropriate combination of education and experience and 5 years’ research study or other relevant experience.
Successful completion of a full course of study 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 3 years’ research study or other relevant experience.
Supervisory or project management experience required.
Must complete NU's IRB CITI training before interacting with any participants and re-certify every 3 years.
Minimum Competencies
Experience with financial systems and reports, particularly regarding clinical trials and interactions with sponsors
Knowledge of clinical trial operations and management, including recruitment and/or coordination
Minimum of 4 years’ experience in clinical research fields
Knowledge of GCP
Preferred Qualifications
BA/BS degree required with Master’s degree preferred
Preferred Competencies
Knowledge of REDCap, NU systems
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 childcare and senior/adult care. Visit 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 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.
#LI-GY2
#J-18808-Ljbffr