Clinical Research Coordinator

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

Target hiring range for this position will be between be $51,346.00 - $55,000.00 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:

Coordinates and completes day to day administrative and technical activities involved in concurrent biomedical &/or social-behavioral research study(ies) involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. The Research Coordinator also coordinates collection, analysis, processing, and reporting of data. Monitors study performance, and reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. 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.
• Ensures completion of study activities per protocol. Collaborating with clinical 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.
• Participates in the planning and conduct of research study including participant recruitment and retention
• Reviews project and protocol and recommends strategies to expedite study(ies)
• Obtains informed consent
• Administers tests and/or questionnaires following protocols
• Submit protocol and informed consent document to NU IRB
• Complete modifications to studies as needed
• Collects, compiles, tabulates and processes responses
• Gathers Information
• Extracts and analyzes data from medical charts
• Completes basic clinical procedures such as buccal swabs, drawing blood and obtaining blood pressure.
• Manage the consenting of patients, data collection, sample/tissue collection, and patient follow-up. Direct activities associated with collaboration including the sending and receiving of samples and data.

Data

• Manages project data including processing, accuracy, & 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.
• Manages study databases, which may include ensuring that data is collected and entered correctly

Administration

• Coordinates 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.
• Ensures appropriate and timely compliance with associated local, state, & federal regulatory guidelines, requirements, & laws; & research protocols.
• Collects, records, reviews and summarizes research data
• Attends all relevant research meetings.
• Functions as a liaison with several collaborators located at other institutions. Coordinates tissue and data sharing, including creation and management of Nondisclosure Agreements, Data Usage Agreements, and Material Transfer Agreements.
• Assists with industry-sponsored trials, including regulatory binder maintenance and audits
• Responsible for documentation of research and clinical data as-needed to meet protocol, clinical practice and audit requirements.

Finance

• May process payments for research participants per study protocol

Supervision

• May provide work direction and/or train other research staff to interview/test participants
• May act as a mentor regarding education of junior coordinators
• 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 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)

• At least 1-2 years prior experience in clinical research or related field
• Specific courses or certifications in clinical research, such as Certified Clinical Research Coordinator (CCRC) or similar certification
• Experience in patient interaction or data management in a clinical setting

Preferred Competencies: (Skills, knowledge, and abilities)

• Understanding clinical research processes including study design and regulatory requirements
• Basic understanding of ethical and regulatory guidelines, including 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 resolve issues that arise during the conduct of a clinical trial or study
• Critical thinking skills to assess and address protocol deviations or 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 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, affordable childcare and senior/adult care. Visit us at 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 us at https://www.northwestern.edu/hr/learning/index.html to learn more.

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