Clinical Research Coordinator

Department: MED-Thoracic Surgery Salary/Grade: EXS/5 Target hiring range for this position will be between be $51,346.00 - $72,532.00 . 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 protocols. Assigns work & may provide oversight to study staff, as well as 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). Compliance with relevant policies of Northwestern University and Northwestern Memorial HealthCare. 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. 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 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 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.) Ability to manage and maintain accurate clinical research documentation and data Familiarity with medical terminology and basic concepts in healthcare and clinical research Strong verbal and written communication skills for interacting with study participants, investigators, and other stakeholders Basic proficiency with Microsoft Office Suite (Word, Excel, Powerpoint) Ability to clearly explain study procedures and obtain informed consent from participants Ability to manage multiple tasks and prioritize effectively Strong attention to detail and accuracy in data collection and documentation Ability to work collaboratively in a team environment Professionalism and ethical conduct in handling sensitive information and interacting with study participants Sensitivity to the needs and concerns of study participants Commitment to ensuring participant safety and well-being throughout the study Preferred Qualifications: (Education and experience) Bachelor’s degree and a minimum of 3 years or master’s degree and minimum of 2 years prior experience in clinical research or related field, Certification in clinical research, such as Certified Clinical Research Coordinator (CCRC) or similar, and/or relevant, documented coursework or continuing education. Experience in patient interaction and data management in a clinical setting, preferably in an Academic Medical Center. Preferred Competencies: (Skills, knowledge, and abilities) Understanding of clinical research regulations and processes, including ethical and regulatory guidelines, such as Institutional Review Board (IRB) procedures and informed consent processes Awareness of patient privacy laws and data protection regulations, such as HIPAA Ability to identify and appropriately resolve issues that may arise during the conduct of a clinical trial or study Critical thinking skills to assess and address interpersonal challenges that arise when working with patients in a health care setting, protocol deviations, and other challenges Benefits At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! 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 . 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