Clinical Research Project Manager
Evanston, ILFull-time
65K a year
Behavioral Health Market Context
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Job Description
y-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).**Specific **
• *Responsibilities**:
Technical
- Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
- Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
- Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
- Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
- Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
Administrative
- Analyzes, evaluates & interprets data to determine relevance to research.
- Assists PI in developing statistical methods & models to analyze & report data based upon study requirements.
- Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
- Creates data for use in grant submission & develop new proposals for research including obtaining financial support.
- Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
- Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Data
- Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
- Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Finance
- May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
- Monitors accounts.
- Negotiates prices & specifications with vendors.
- Purchases supplies, materials, equipment & services.
- Ensures appropriate allocation & compliance.
- Invoices study sponsors for study tests/procedures.
- Coordinates & participates in budgetary negotiations with industry sponsors.
Supervision
- Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows.
- Acts as a mentor in regard to education of junior coordinators**_. _**
• *_Miscellaneous _**
_Performs other duties as assigned_
• *Minimum Qualifications: (Education, experience, and any other certifications or clearances)**
- Successful completion of a full 4-year course of study in 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 5 years' research study or other relevant experience required; OR
- Successful completion of a full course of study in 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 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 & must re-certify every 3 years.
• *Minimum Competencies: (Skills, knowledge, and abilities.)**
- Experience with financial systems and reports, particularly with regard to clinical trials and interactions with federal and non-federal sponsors
- Knowledge of clinical trial operations and management, either in recruitment and/or coordination
- Minimum of 4 years’ experience in clinical research fields
- Knowledge of GCP
• *Preferred Qualifications: (Education and experience)**
- BA/BS degree required with Masters degree preferred
• *Preferred Competencies: (Skills, knowledge, and abilities)**
- Knowledge of REDCap, NU systems
• *Responsibilities**:
Technical
- Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
- Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
- Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
- Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
- Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
Administrative
- Analyzes, evaluates & interprets data to determine relevance to research.
- Assists PI in developing statistical methods & models to analyze & report data based upon study requirements.
- Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
- Creates data for use in grant submission & develop new proposals for research including obtaining financial support.
- Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
- Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Data
- Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
- Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Finance
- May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
- Monitors accounts.
- Negotiates prices & specifications with vendors.
- Purchases supplies, materials, equipment & services.
- Ensures appropriate allocation & compliance.
- Invoices study sponsors for study tests/procedures.
- Coordinates & participates in budgetary negotiations with industry sponsors.
Supervision
- Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows.
- Acts as a mentor in regard to education of junior coordinators**_. _**
• *_Miscellaneous _**
_Performs other duties as assigned_
• *Minimum Qualifications: (Education, experience, and any other certifications or clearances)**
- Successful completion of a full 4-year course of study in 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 5 years' research study or other relevant experience required; OR
- Successful completion of a full course of study in 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 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 & must re-certify every 3 years.
• *Minimum Competencies: (Skills, knowledge, and abilities.)**
- Experience with financial systems and reports, particularly with regard to clinical trials and interactions with federal and non-federal sponsors
- Knowledge of clinical trial operations and management, either in recruitment and/or coordination
- Minimum of 4 years’ experience in clinical research fields
- Knowledge of GCP
• *Preferred Qualifications: (Education and experience)**
- BA/BS degree required with Masters degree preferred
• *Preferred Competencies: (Skills, knowledge, and abilities)**
- Knowledge of REDCap, NU systems
Qualifications
- •*Minimum Qualifications: (Education, experience, and any other certifications or clearances)**
- •Successful completion of a full 4-year course of study in 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 5 years' research study or other relevant experience required; OR
- •Successful completion of a full course of study in 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 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 & must re-certify every 3 years
- •*Minimum Competencies: (Skills, knowledge, and abilities.)**
- •Experience with financial systems and reports, particularly with regard to clinical trials and interactions with federal and non-federal sponsors
- •Knowledge of clinical trial operations and management, either in recruitment and/or coordination
- •Minimum of 4 years’ experience in clinical research fields
- •Knowledge of GCP
- •Knowledge of REDCap, NU systems
Benefits
Responsibilities
- •Manages all activities associated with biomedical &/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; &/or multi-million dollar budgets
- •Ensures completion of contract requirements & client specifications
- •Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner
- •May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants
- •Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).**Specific **
- •Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives
- •Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities
- •Oversees completion of study activities per protocol
- •Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules
- •Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors
- •Manages conduct of experimental tests & procedures
- •Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule
- •Reviews scientific literature & evaluates & recommends applicable techniques & procedures
- •Analyzes, evaluates & interprets data to determine relevance to research
- •Assists PI in developing statistical methods & models to analyze & report data based upon study requirements
- •Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc
- •Creates data for use in grant submission & develop new proposals for research including obtaining financial support
- •Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions
- •Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner
- •Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives
- •Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports
- •Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data
- •May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget
- •Monitors accounts
- •Negotiates prices & specifications with vendors
- •Purchases supplies, materials, equipment & services
- •Ensures appropriate allocation & compliance
- •Invoices study sponsors for study tests/procedures
- •Coordinates & participates in budgetary negotiations with industry sponsors
- •Supervision
- •Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows
- •Acts as a mentor in regard to education of junior coordinators**_
- •_Performs other duties as assigned_