Research Study Coordinator

Department: MED-Ctr Tran Metabolism Health
Salary/Grade: NEX/11

Job Summary:

The Research Study Coordinator will be stationed at the Center for Translational Metabolism and Health within the Institute for Public Health and Medicine (IPHAM), supporting the research initiatives of Dr. Tamara Isakova. The primary responsibilities include:

• Participant Identification: Conducting medical record reviews and collaborating with local physicians to identify potential study participants.
• Informed Consent: Obtaining informed consent from participants, thoroughly explaining study procedures, risks, and benefits.
• Study Coordination: Assisting the principal investigator in verifying inclusion/exclusion criteria, scheduling and coordinating study visits, and conducting data collection procedures. This includes collecting vital signs, blood and urine samples, administering study medications or procedures, and completing study questionnaires.
• Laboratory Management: Overseeing laboratory procedures, including sample collection, processing, packaging, and shipping.
• Participant Safety: Monitoring for adverse events and reporting any serious concerns to the principal investigator, institution, and regulatory bodies.
• Regulatory Compliance: Collaborating with the principal investigator to ensure adherence to regulatory standards by facilitating the development, maintenance, and ongoing review of comprehensive regulatory documentation.
• Data Management: Maintaining accurate study data in compliance with Good Clinical Practice (GCP) standards.
• IRB Documentation: Supporting the principal investigator with regulatory compliance and the creation and maintenance of Institutional Review Board (IRB) documentation.
• Communication: Effectively communicating with study participants, providing updates on study progress, and addressing questions or concerns.

All activities must be conducted in strict adherence to Good Clinical Practices (GCP) and relevant local, state, and federal laws, regulations, guidance, policies, and procedures established by the NU IRB, FDA Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).

Specific Responsibilities:

Technical

• Participates in the planning & conduct of research study including participant recruitment and retention.
• Obtains informed consent
• Administers tests &/or questionnaires following protocols.
• Collects, compiles, tabulates & processes responses.
• Extracts & analyzes data from medical charts.
• Completes basic clinical procedures such as drawing blood & obtaining blood pressure.

Administration

• Collects, records, reviews & summarizes research data.
• Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests.
• Prepares reports for investigators and sponsors on recruitment status and other pertinent study data.
• Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols.

Finance

• May process payments for research participants per study protocol.
• Works with industry representatives to negotiate tentative grant funding.
• Creation of study budgets and proper invoicing of study sponsors

Supervision

• May provide work direction &/or train other research staff to interview/test participants.
• May act as a mentor in regard to education of junior coordinators.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• 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.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.

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

• Working knowledge of spreadsheets and data
• Ability to write and communicate clearly.
• Ability to complete administrative documents.

Preferred Competencies: (Skills, knowledge, and abilities)

• Experience collecting and/or coding qualitative data
• Experience collecting data with REDCap, Qualtrics, and sponsor databases(iMedidaRave/Clintrak)
• Data management skills with Microsoft Access, R, or similar software

Target hiring range for this position will be between $19.89 - 24.86 per hour. 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 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.

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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