Research Study Coordinator Senior

Department: MED-Preventive Medicine
Salary/Grade: NEX/13

Target hiring range for this position will be between $48,441.60 - $50,000 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.

Job Summary:

This position is funded through March 31st, 2027.

Coordinates & completes the day to day administrative & technical activities involved in a single complex, large, nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research study(ies) involving multiple sites& /or longitudinal assessments/ interventions. Ensures that all activities are completed by strictly following Good Clinical Practices (GCP) & all relevant 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).

The selected candidate will coordinate study operations of the All of Us Research Program (AoURP) and Nutrition for Precision Health (NPH). The All of Us Research Program is a historic, longitudinal effort to gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, socioeconomic status, environment, and biology, researchers will uncover paths toward delivering precision medicine, or individualized prevention, treatment, and care. The Northwestern University All of Us Research Program team is part of this ambitious effort and aims to enroll more than 30,000 participants across the health system.

Nutrition for Precision Health (NPH) is the first ancillary study of the All of Us Research Program. The NPH program will build on recent advances in biomedical science, including artificial intelligence and microbiome research, as well as the infrastructure and large, diverse participant group of the All of Us Research Program. These advances provide unprecedented opportunities to generate new data and offer insight into personalized nutrition, also referred to as precision nutrition.

This position will be based in Northwestern Medicine medical facilities in downtown Chicago and will be responsible for meeting study milestones. The selected candidate will be responsible for performing biomedical and/or social-behavioral research by administering tests and/or questionnaires following protocols; collecting, compiling, tabulating, and/or processing responses; gathering information; and/or assisting in the preparation of materials for inclusion in reports. They will also be responsible for recruiting participants for an ongoing research study under the direction of the Project Manager and PI, and for setting appointment days and times with participants via phone calls, text messages, email exchanges, and a web-based appointment scheduling system. Other responsibilities include data collection procedures, lab procedures, inventory, shipping, daily lab operations, and study procedures as needed.

Completes all activities by strictly following Good Clinical Practice (GCP) and all relevant current local, state, and federal laws, regulations, guidance, policies, and procedures developed by the NU Institutional Review Board (IRB), the Food and Drug Administration (FDA), the Code of Federal Regulations (CFR), and the International Council for Harmonisation (ICH).

Please note: This position may be required to work a varied schedule, depending on the needs of the study.

Specific Responsibilities:

Technical

• Participates in the planning & conduct of research studies.
• Reviews project & protocol & recommends strategies to expedite study.
• Recruits & retains participants.
• Obtains informed consent.
• Administers tests &/or questionnaires following protocols.
• Collects, compiles, tabulates &/or process responses.
• Gathers information.
• Extracts & analyzes data from medical charts.
• Completes basic clinical procedures such as drawing blood & obtaining blood pressure.
• Monitors & maintains systems for effective participant and data flow for studies.
• Designs & constructs experimental stimuli.
• Performs physical function assessment.
• Closely monitors & documents patient's adverse events and report to Clinical Operations Manager as necessary
• Ensures that study protocols are in compliance with guidelines & regulations.
• Reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
• Participant recruitment, presentations, attending events as needed

Administration

• Manages study databases which may include ensuring that data is collected & entered correctly.
• Reviews & analyzes data.
• Creates computer models, graphs, reports & summaries for use in publications, professional journals, & grant applications.
• Writes portions of grant applications.
• Co-authors scientific papers for presentation & publication.
• Researches & obtains funding.
• Creates & maintains study manuals regarding operating, safety, and etc. procedures.
• Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.

Finance

• May process payments for research participants per study protocol.
• Creates lab financial plan & budget/audit expenses.
• Obtains sales quotes for lab equipment & supplies.
• Reviews & adjusts expenses to decrease costs.
• Oversees repair & maintenance of all lab equipment & ensures that lab supplies are ready & available when necessary.
• Administers budget including negotiating with grant sponsors.
• Maintains & reconciles expenditures & balances in regard to research accounts & budgets.
• Assist in purchasing of supplies, materials, equipment & services.
• Ensures appropriate allocation & compliance.

Supervision

• Trains, directs, assigns duties to & may supervise research staff, students, residents &/or fellows.
• Acts as a mentor in regard to education of junior coordinators.

Miscellaneous

Performed other duties

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 4 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 2 years' 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.)

• Knowledge of all aspects of clinical research, including laboratory work, clinical exams, and supervision of staff.
• Must be able to handle multiple responsibilities and deadlines while keeping the study on track and meeting the accrual goals.
• Must be able to remain steady under pressure, be adaptable, take direction from others, and be a team player.
• Attention to Detail: Consistently displays accuracy and attention to detail.
• Excellent time management and communication skills.
• Ability to communicate clearly and concisely both orally and in writing
• Problem solving: Ability to troubleshoot and implement solutions

Preferred Qualifications: (Education and experience)

• Experience working with research teams to identify, enroll, and collect data
• Knowledge of behavioral medicine research theories and methods preferred
• Develop and maintain Standard Operating Procedures (SOPs)
• Prior supervisory experience.

Preferred Competencies: (Skills, knowledge, and abilities)

• An engaging and energetic personality
• Ability to transmit excitement and passion for the project to potential participants.
• Phlebotomy trained.

A well-qualified candidate within this department or unit has been identified and will be considered for the position along side other qualified candidates identified through a competitive recruitment process. The University reserves its right to give priority consideration to internal qualified candidates.

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 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.