Department: MED-Preventive Medicine Salary/Grade: NEX/11
The Research Study Coordinator role coordinates collection, analysis, processing and reporting of data & assists Principal Investigator (PI) and Clinical Research Project Manager in judging the validity of test data obtained in regard to biomedical and/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses and/or universities. Completes all activities 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), and the International Conference on Harmonization (ICH).
The selected candidate will coordinate study operations of the All of Us Research Program (AoURP), which is part of the Precision Medicine Initiative within the Northwestern network. AoURP is an unprecedented large-scale, multi-site study that will enroll 31,000 participants within Northwestern Medicine over 5 years. This position will be based in Northwestern Medicine medical facilities in the North and/or West suburbs of Chicago, and will be responsible for meeting enrollment milestones in their assigned region(s). The selected candidate will be responsible for coordination and implementation of participant scheduling and data collection procedures as well as engaging service providers, and recruiting participants to the research program in their region.
This position may be required to work a varied schedule, depending on the needs of the study. Evening and weekend work may be required if the study conducts participants visits or recruitment sessions during those times. It is anticipated that the selected candidate will arrange their schedule to ensure adequate oversight of the clinical locations and the study operations in general.
Participates in the planning & conduct of research study including participant recruitment and retention.
Obtains informed consent
Administers tests and/or questionnaires following protocols.
Completes basic clinical procedures such as drawing blood & obtaining blood pressure and physical measurements.
Closely monitors and documents patient’s adverse events and reports to Clinical Research Manager as necessary.
Ensures that study protocols are in compliance with appropriate rules & regulations. Reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
Collects, records, reviews and summarizes research data.
Collates relevant mathematical results & prepares tables, charts and 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.
Acts as liaison between Northwestern Medicine physicians, nurses, practice managers, and Northwestern All of Us research team managers to fulfill enrollment goals.
May process payments for research participants per study protocol.
Implement research study budget, which may include deciding on & approving expenditures of funds based on budget.
Assist in purchasing of supplies, materials, equipment & services.
Ensures appropriate allocation & compliance.
Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget.
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.
Responsible for training and certifying staff on study procedures.
Performs other duties as assigned.
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 Northwestern University'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.Must be willing to travel to, and work at, various sites around the city and/or suburbs that will be the designated locations for this study.As needed, this position will need to conduct participant visits to assist the staff with their workload.
Preferred Competencies: (Skills, knowledge, and abilities)
Willingness to pitch in and help the study team members wherever help is required.
Must have an engaging, energetic personality, excellent communication skills, and be able to transmit excitement and passion for the project to potential participants.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 36285
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.