The Senior Research Study Coordinator 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).
Please note: Recruitment of participants may require evening and weekend hours at the office. If this occurs the work week remains 40 hrs.
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.
Extracts & analyzes data from medical charts.
Monitors & maintains systems for effective participant and data flow for studies.
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.
May process payments for research participants per study protocol.
Creates lab financial plan & budget/audit expenses.
Obtains sales quotes for lab equipment & supplies.
Oversees repair & maintenance of all lab equipment & ensures that lab supplies are ready & available when necessary.
Trains, directs, assigns duties to & may supervise research staff, students, residents &/or fellows.
Acts as a mentor in regard to education of junior coordinators.
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 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 Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Prepare REDCap survey.
Perform onboarding of voluntary, part-time and full-time research assistants, including telephone privileges, computer access, printing access, inform about CITI certification.
Prepare an application for submission to the IRB and submit amendments.
Maintain the regulatory binder for NIH funded research.
English language fluency with an engaging personal style for telephone recruitment.
Manage personnel with direct reporting relationship – expected time to complete a task, set deadlines for work performance.
Plan data safety and monitoring committee meetings and workshops.
Recent (within the last year) or current 2 years as a clinical research coordinator for NIH funded behavioral or clinical research with excellent references.
Certification as a clinical research coordinator.
Prepare annual program reports for submission to funding organizations.
Preferred Competencies: (Skills, knowledge, and abilities)
Word Processing with the ability to format grant applications, creation of PowerPoint slides, Excel to create graphs.
Adept at problem solving with the ability to clearly summarize the situation and offer a range of solutions.
As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
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.
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 highl...y collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.