Department: MED-Neurological Surgery
Salary/Grade: EXS/5

Job Summary:

The Clinical Research Coordinator in the Northwestern University Feinberg School of Medicine Department of Neurological Surgery 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).

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.

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.
• 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

Preferred Qualifications: (Education and experience)

• Experience as a clinical research coordinator, including proficiency with protocol implementation GCP, and regulatory requirements; verifying completeness and accuracy of patient and clinical trial data; completing reporting requirements in electronic data capture (EDC); and ensuring adverse events are reported in accordance with protocols.
• Experience with study closeout visits (ensuring all regulatory and data requirements are complete prior to closing the study at site).

Preferred Competencies: (Skills, knowledge, and abilities)

• An interest in nervous system and/or neuro-oncology research, quality and outcomes is strongly preferred.
• Ability to build rapport with multidisciplinary teams including surgeons, nurses, residents, other clinical and scientific professionals.
• Demonstrated ability to follow detailed instructions and protocols with an attention to detail, a methodical approach to work, and accurate recordkeeping.
• Strong interpersonal skills and an ability to communicate effectively at all levels.
• A proven ability to organize, take initiative and follow-up independently.
• Strong planning, organization, and prioritization skills in order to meet demanding timelines.
• Proficiency in Microsoft Office and EDC systems.
• Ability to work independently, as well as collaboratively in a team environment, both in the inpatient and outpatient settings.
• Ability to apply high-level judgment to report issues that may impact the conduct of the study.

Target hiring range for this position will be between $60,000 - $70,000 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.

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.

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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.

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