Job Description

Department: MED-Clinical Trials Unit
Salary/Grade: EXS/5

Target hiring range for this position will be between $51,346 - $64,473 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 &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. Monitors study performance, analyzes & review results, & supervises development & implementation of new protocols. Assigns work & supervises study staff & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. 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).

On site activity is expected 4-5 days per week

Specific Responsibilities:

Technical

• Leads execution & control of a biomedical &/or social science project or research study.
• Manages and ensures 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.
• Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
• On site activity is expected 4-5 days per week

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.

Administration

• Manages project, collaborating and partnering with all internal/external staff including sponsoring agencies, organizations &/or other research &/or educational institutions to ensure project objectives and timelines are attained. Advises project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project.
• Manages day-to-day project operational & business functions; implements existing policy & ensures the effective, compliant, & efficient completion of daily administrative operations.
• Ensures appropriate and timely compliance with associated local, state, & federal regulatory guidelines, requirements, & laws; & research protocols.

Miscellaneous

Perform 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 2 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 1 year research study or other relevant experience.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years

Minimum Competencies: (Skills, knowledge, and abilities.)

• A bachelor's degree in a social or health science + 2 years' experience; or 4 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years

Preferred Qualifications: (Education and experience)

• Experience working with the cardiovascular population

Preferred Competencies: (Skills, knowledge, and abilities)

• Enhanced clinical understanding of the cardiovascular population
• Familiarity with hospital electronic systems (i.e. electronic medical records, IDX, Cadence)

Benefits:

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at 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 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 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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